Amgen Jobshttp://www.amgen.jobs2012-05-27 00:55:06.713660USAThousand OaksAuto req 15609BR Job Posting Title GRAAS Operations Senior Manager Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The focus of this group is to support the business and project needs of the GRAAS International Region through detailed strategic planning and delivery of analytical, logistical, financial, and organisational data, support and advice. Specifically, this job provides comprehensive strategic business & operations support within GRAAS International across a broad range of strategic issues (governance, organisation, productivity, etc.) and assist the GRAAS International Core Senior Management Team (SMT) in effective and productive leadership and management of the GRAAS International business and organisation and internal and external communication. Key activities include: - Provide strategic and operational support including strategic planning and communications, operational project management and implementation of functional projects - Contribute through SME or facilitation to department and/or cross-functional projects and process improvement initiatives - Support for the (sub-functional) leadership through tracking of project progress, issue tracking, problem solving, organizational management, and presentation development - Implement tools, techniques and processes to enable continuous improvement across GRAAS International regions - Provide cross-functional and GRAAS internal communications where applicable - Support and/or direct leadership of various external development initiatives partnering with global functions and regional leaders - Provide strategic analysis managing benchmarking to capture industry best practices, organization design and operations for critical business functions - Develop and manage budgets and contribute to the International budget process (if requested) - Manage special projects, as required. - Ensure cross-functional liaison (e.g. ICO, GDO, Operations) - Contribute through influence and direct support to the activities and goals of other international functions - Support to GRAAS International VP and /or GRAAS International Core Senior Management Team (SMT)members with International governance forums (e.g. IMC, ISC, EMST and RMCs) Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - Solid understanding of working within global complex matrix organisations - Ability to engage different personalities - Ability to influence - Motivating and leading (cross functional) teams on a functional level - Strong critical thinking - Planning and Prioritisation - Good interpersonal skills - Knowledge of the fields of Regulatory & Safety and biopharmaceutical industry - Excellent communication skills - Experience of working with and for senior executives - Stakeholder management - Presentation skills - Microsoft Office applications - Basic Financial Understanding - Project management tools and methodologies - Change Management2012-05-18 18:06:17United StatesAmgenCalifornia15609BRCAThousand Oaks, CA28792882http://www.amgen.jobs/xml/28792882/jobUSAThousand OaksAuto req 15520BR Job Posting Title Regulatory Affairs Director (Policy, Biosimilars) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description GRAAS Biosimilar Policy is accountable for defining Amgen positions on the scientific, medical and regulatory aspects of biosimilars and advocating those standards to external policy makers while concurrently providing key internal subject-matter expertise to cross-functional executive leadership and teams. Job Summary: - Develop, direct and deliver strategic regulatory plans that are in-line with regulatory and business needs - Develop innovative solutions to complex problems through in-depth analysis, coordination and negotiation with subject-matter experts and key decision makers - Work in partnership with cross-functional teams and Amgen leadership to develop regulatory plans that support the direction of the business - Influence a broad spectrum of internal and external stakeholders toward achieving regulatory and business goals - Develop mutually beneficial strategic alliances with internal and external subject matter experts and external key decision makers - Engage in direct advocacy with national, regional and global policy makers and regulators - Represent Amgen and the innovator industry in policy testimony and on trade association key issue teams This position could be located in Thousand Oaks California, or Washington D.C. Basic Qualifications - Doctorate degree and 4 years of directly related experience OR - Master's degree and 8 years of directly related experience OR - Bachelor's degree and 10 years of directly related experience Preferred Qualifications Knowledge and Skills - Science background - Experience in regulatory or clinical development, ideally with biologics - Understanding of national a d global healthcare system, including payers - Critical thinker, able to analyze and critique data - Intellectually creative, able to assess a situation from multiple perspectives - Skilled and credible advocate with experience in 1:1 engagement, large audiences, panel debates - Able to form and defend a position under challenge2012-05-04 19:32:33United StatesAmgenCalifornia15520BRCAThousand Oaks, CA28441221http://www.amgen.jobs/xml/28441221/jobUSAThousand OaksAuto req 15571BR Job Posting Title Regulatory Affairs Director (CMC Lead) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Biosimilars are an important new development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar developments requires integrating all of the analytical science and quality manufacturing experience at Amgen to creatively and rapidly demonstrate comparability to originator products. To facilitate the process and efficient global registrations of the Amgen biosimilar portfolio, the Director for CMC Regulatory Affairs, Biosimilars, will lead the development and execution of regulatory CMC and analytical similarity strategies. Job Summary: - Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory CMC and analytical similarity strategies - Facilitate effective global regulatory agency interactions for product manufacturing and quality programs - Define and execute long-term global CMC regulatory plans for licensed biosimilar products Responsibilities include: Regulatory Strategy and Filing - Provide expertise and leadership in the development, communication, and implementation of global CMC and analytical similarity regulatory strategies in support of biosimilar goals and product portfolio execution - Lead cross-functional teams in development and submission of CMC, quality, and analytical similarity regulatory documents - Accountable for generation and submission of CMC and quality regulatory documents, including CTAs, MAs, and RTQs, are developed with high quality, delivered in a timely manner, consistent with the overall biosimilar strategies, and compliant with current regulatory authority requirements - Ensure product licenses are maintained per regulatory requirements and consistent with biosimilar strategy and long-term planning - Support development and execution of clinical/ non-clinical strategies Regulatory Interactions - Plan, execute and lead agency CMC meetings per regulatory strategy - Facilitate ad hoc CMC-related interactions, RTQ responses and meetings - Represent the Biosimilars Operating Unit in the coordination and conduct of prior-approval and GMP inspections by regulatory authorities Regulatory CMC - Design, plan and execute regulatory CMC strategies - Scientific oversight of development and delivery of analytical similarity regulatory packages that meet biosimilar regulatory requirements - Delivery of CMC information in regulatory documents (including CTAs, MAs, analytical similarity assessments, requests for information, CMC related agency interactions) - Represent RA CMC on appropriate teams - Manage priorities and resources for multiple products Regulatory Intelligence - Monitor, assess and implement regional regulatory requirements - Assess impact of regulatory decisions for competitive products - Generate and communicate biosimilar intelligence to the Biosimilars Operating Unit and Amgen innovative teams as appropriate Biosimilars Policy - Provide subject matter expertise to GRAAS Biosimilar Policy function Collaboration - Support vendor oversight and management for regulatory CMC operations - Exchange biosimilar CMC and analytical similarity regulatory requirements with regulatory colleagues on an ongoing basis Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Master’s degree & 8 years of directly related years OR - Bachelor’s degree & 10 years of directly related experience Preferred Qualifications -4+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources - Experience in the biosimilars/ biotechnology industry - Experience in interacting with regulatory agencies - Regulatory submissions experience - Experience interacting with senior regulatory agency representatives - Knowledge of global regulations - Familiarity in working with policies, procedures and SOPs - Understanding of drug development - Industry experience in manufacturing, process development, and testing (QC/QA) - Experience in analytical similarity or comparability assessments and development of associated packages - Leadership experience in a functional environment - Comprehensive understanding of Regulatory functional activities and how they affect projects and processes - Global regulatory experience with product filings - Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood - Experience communicating and clearly presenting strategic and business issues - Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment - CMC-specific and analytical-specific regulatory knowledge and experience - Ability to understand and communicate scientific and clinical information - Ability to anticipate and prevent potential issues - Ability to manage and mentor others - Cultural awareness and sensitivity to achieve results across different regions2012-05-04 19:30:47United StatesAmgenCalifornia15571BRCAThousand Oaks, CA28441117http://www.amgen.jobs/xml/28441117/jobUSAThousand OaksAuto req 15534BR Job Posting Title Regulatory Affairs Mgr (Scientific Writer) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. Job Summary: - Draft scientific, CMC, and regulatory documents that conform to global regulatory requirements, Amgen and industry standards, and accepted templates. - Manage review and approval of scientific, CMC, and regulatory documents; engage members of cross-functional teams to address and resolve issues in accordance with established timelines. - Ensure the accuracy, adequacy, and consistency of documents. - Provide writing expertise to project teams. Key Activities: - Write Scientific, CMC, and Regulatory Documents - Independently write documents in support of product registrations and global filings, eg, briefing documents, responses to regulators’ questions, and Quality-related sections of INDs, CTAs, Analytical Packages, and CTDs. - Participate in the development of study timelines for regulatory documents. - Implement quality control for review and finalization of documents. - Ensure finalized documents are filed and archived appropriately. - Assist with process development initiatives to meet internal needs. - Maintain Writing Expertise and Awareness of Regulatory Environment - Seek opportunities to continue developing writing and editorial skills. - Keep abreast of regulatory requirements that affect work projects. - Collaborate with multidisciplinary teams across global regions. - Negotiate final content and format of dossiers. - Represent Biosimilars Regulatory Affairs on committees, as requested Basic Qualifications - Doctorate degree OR - Master’s degree and 3 years of directly related experience OR - Bachelor’s degree and 5 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED and 12 years of directly related experience Preferred Qualifications - Degree in Life Sciences or related field - Experience in the biosimilars/ biotechnology industry - Regulatory submissions experience - Regulatory knowledge of global regulations - Working with policies, procedures, and SOPs - Understanding of drug development Knowledge and Skills - Ability to analyze data, and to collaborate with subject matter experts outside one’s own areas of scientific expertise. - Good knowledge and experience with time management and timeline development. - Ability to work with remote workers. - Attention to detail. - Flexibility. - Strong oral and written communication skills. - Ability to understand and communicate scientific and CMC information. - Ability to discern areas of potential concern and communicate concerns effectively to manager. - Cultural awareness and sensitivity to achieve results across different regions.2012-04-30 18:51:01United StatesAmgenCalifornia15534BRCAThousand Oaks, CA28273711http://www.amgen.jobs/xml/28273711/jobUSAThousand OaksAuto req 15474BR Job Posting Title Dir Regulatory Affairs (Global, Biosimilars) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this group is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. Job Summary: - Provide global regulatory leadership and support to the Amgen Biosimilars Operating Unit - Facilitate product development and global registration of the Amgen biosimilar portfolio by developing and executing regulatory strategies - Ensure that regulatory approvals to support clinical trials are acquired and maintained - Achieve desired global labeling that are compliant with regulatory requirements - Manage effective interactions with regulatory authorities Key Activities: Regulatory Strategy & Filing - Provide expertise and leadership in the development, communication, and implementation of approved global regulatory strategies and plans in support of biosimilar goals and product portfolio execution - Lead and provide regulatory direction to cross-functional teams - Ensure regulatory documents are developed with high quality, delivered in a timely manner, consistent with biosimilars strategies, and compliant with current global regulatory authority requirements - Ensure all filings are maintained per regulatory requirements - Ensure development and execution of clinical/ non-clinical strategies, including regulatory review, input and advice for study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports, and related regulatory documents required to support product development and registration - Ensure development of product labels and core data sheets - Identify process needs to meet internal challenges Regulatory Interactions - Plan, execute and lead agency meetings per regulatory strategy - Lead the generation and submission of briefing books to support regulatory interactions - Facilitate ad hoc interactions, RTQ responses and meetings - Ensure coordinated planned and ad hoc contacts with regulatory authorities on the development and registration of biosimilar products Regulatory Intelligence - Monitor, assess and implement regional regulatory requirements - Review and assess impact of regulatory decisions for competitive products - Ensure that biosimilar regulatory intelligence gained by the Biosimilars Regulatory Function is communicated to the Biosimilars Operating Unit, other Amgen functions and partners as appropriate Biosimilars Policy - Provide subject matter expertise to GRAAS Biosimilars Policy function as required Collaboration - Ensure that regional regulatory activities are appropriately coordinated with Amgen affiliates - Support vendor oversight and management for regulatory and safety operations - Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function - Represent Biosimilars Regulatory Affairs on committees, as necessary - Share insights on biosimilar regulatory requirements with colleagues Basic Qualifications - Doctorate degree and 4 years of directly related experience OR - Master's degree and 8 years of directly related experience OR - Bachelor's degree and 10 years of directly related experience AND 4 years of direct managerial and /or leadership experience Preferred Qualifications - Experience in the biosimilars/ biotechnology industry - Experience in interacting with regulatory agencies - Regulatory submissions experience - Experience interacting with senior regulatory agency representatives - RAC - Regulatory knowledge of global regulations - Familiarity in working with policies, procedures and SOPs - Understanding of drug development - Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes - Regulatory experience with product filings - Experience interacting and communicating with senior executives and teams regarding strategic issues to ensure expectations are understood - Experience communicating and clearly presenting strategic and business issues - Experience leading teams and projects in a global, complex, dynamic, regulated matrix environment - Deep knowledge of strategic management models and frameworks - Ability to understand and communicate scientific and clinical information - Ability to anticipate and prevent potential issues - Ability to manage and mentor others - Cultural awareness and sensitivity to achieve results across different regions2012-04-26 18:20:02United StatesAmgenCalifornia15474BRCAThousand Oaks, CA28203630http://www.amgen.jobs/xml/28203630/jobUSAThousand OaksAuto req 15102BR Job Posting Title Regulatory Affairs Director (Asia/China) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this role is to facilitate registration of Amgen products in Asia, with a focus on China, through executing our international expansion plans; providing strategic regulatory expertise; interfacing with agencies on regulation; aligning with key Amgen cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent. Specifically: - Regulatory expert providing support to commercialize Amgen products in one or more priority programs in a Therapeutic Area Team(s) - Provide regulatory support to advance the pipeline in Asia with a focus on China - Primary regulatory liaison between the GRT, PSTs, the country offices. Will provide regulatory guidance to GRT, PSTs and support various Amgen teams involved in drug development and commercialization in Asia with a focus on China - The country GRAAS office may report into this position Responsibilities: - Provide leadership and manage various regulatory teams based in countries or regional hubs in the development and execution of regulatory strategies at the country/regional level by maintaining current knowledge of the regulatory requirements - Participate in the development of regulatory strategies by leading various Amgen teams on the regional regulatory requirements for submissions. Support the development and implementations of regional registration and compliance strategies of new and current products - Lead PST members and other teams for regulatory activities to ensure effective interactions with regulatory agencies in the region - Organize and manage various meetings for regional regulatory deliverables including Clinical Trial application (CTA), Marketing Application (MA) submissions and agency interactions - Oversee internal stakeholders and external vendor/contractor relationships - Review routine regulatory correspondence - Ensure QC of regulatory documentation - Ensure collection of functional documents in support of regulatory applications - Ensure development and maintenance of CTA/MA documentation in collaboration with Amgen product teams and the GRAAS regional hubs - Contribute to creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communications. - Ensure regulatory obligations in relation t the product are properly handled - Works actively cross functionally within the various Amgen teams to coordinate activities related to CTA and MAAs - Evaluation of preferred vendors (CTOs, consultants, contractors - Provide strategic and timely regional regulatory input to RT, GDT, GOT and other cross-functional project meetings - Conduct contingency regulatory planning/risk assessment for regional development strategies and agency interactions - Evaluate and communicate impact of relevant regional regulations, guidance and current regulatory environment - Participate actively in various industry working groups to anticipate / evaluate the impact of new regulations and/or changes to the valid and current regulations - Provide leadership and expertise and guidance on teams for interdepartmental and cross-functional teams including, process improvement standards development, and metrics - Develop and deliver training materials on regulatory affairs for intra- and inter-functional purposes - Act within Amgen financial policies and request appropriate funds for filings - Coordinate preparation of controlled documents to ensure regulatory affairs operate in compliance with all regulatory duties and work in compliance with all relevant controlled documents Basic Qualifications - Doctorate degree and 4 years of directly related experience OR - Master’s degree and 8 years of directly related experience OR - Bachelor’s degree and 10 years of directly related experience Preferred Qualifications - Mandarin language - Good understanding of Chinese regulatory landscape Knowledge and Skills: - Demonstrated knowledge of Asian regulations, policies, procedures, drug development guidelines and compliance - Strong communications skills – oral and written - Highly developed regulatory project management skills - Ability to work with high degree of autonomy - Ability to influence and motivate others outside of direct line of authority - Relies on extensive experience and judgment to plan and accomplish goals and objectives - Ability to understand and communicate scientific/clinical information - Demonstrable ability to manage several complex projects in parallel - Relies on extensive experience and judgment to plan and accomplish goals and objectives - Ability to influence and motivate others outside of direct line of authority2012-04-13 02:21:48United StatesAmgenCalifornia15102BRCAThousand Oaks, CA27868772http://www.amgen.jobs/xml/27868772/jobUSAThousand OaksAuto req 14575BR Job Posting Title Sr Mgr GRAAS Operations (Strategy and External Operations) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role shapes and drives key GRAAS and corporate initiatives delivering productivity and operational excellence, in particular sourcing. - Influence and execute transformational business strategies particularly Amgen’s global operating model and sourcing - Deliver productivity/op-ex initiatives including design and leadership of selected process improvements in partnership with GRAAS and corporate leaders - Lead all aspects of financial value capture from these initiatives including financial modeling, allocations, NPV recovery, and support budgeting and planning - Provide execution of global sourcing strategies, and other GRAAS strategies Key Activities of this role include: -Supplier Management - Lead ongoing oversight of supplier engagement - Review and approve metrics/targets for supplier operations - Lead/participate in resolution of business / financial / productivity or site operatins issues with suppliers - Support/lead management of supplier operations (i.e. scheduling, expenses, status reporting, issue/risk management etc.) - Support monitoring of completion of work in accordance with service level agreements (SLAs) and contracts - Leverage best practices in project management to ensure quality performance from supplier - Full ownership of the financial models used/needed for GRAAS to oversee productivity targets, financial value capture, and supplier financials - Review and maintain KCI, KPS, Metrics, compliance related documentation, and conduct / complete RCA / CAPA activities - Oversee supplier operational/process improvement - Strategy and External Operations - Monitor and ensure achievement of desired productivity benefits from strategic initiative. Support development and maintenance of GRAAS Performance Scorecards. Develop financial and operational models to ensure achievement of business benefits. Help secure ELT approval of strategic initiatives by determining validity, expected ROI, and risk:benefit effects - Hands-on leadership of strategic programs and process improvements through planning and implementation. Support/drive various new outsourcing initiatives and partner with GRAAS functions - Support other GSEO projects driving operational excellence in alliances, mergers, and acquisitions Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree or & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience AND - 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications Knowledge and Skills: - Interacting and communicating with senior executives on strategic subjects - Communicating and presenting clearly on strategic and business issues - Motivating and leading teams and projects in a global complex matrix environment - Excellent interpersonal, organizational, supervisory, collaboration and leadership skills - Experience managing cross-functional policy and business initiatives - Experience implementing business change - Crating and updating financial modeling and business value forecasting - Knowledge of strategic management, performance improvement , and change management models - Extensive knowledge of continuous improvement methodologies - Proficiency in anticipating and resolving problems - Understanding of information technology and R&D systems including safety and regulatory technologies - Knowledge of process improvement methodologies - Knowledge of project management tools and methodologies - Experience managing and working with various vendors - Knowledge of communications tools and processes (SharePoint) - Strong computer literacy, including word processing, presentation, spreadsheet, project and web products - Experience in life sciences or medically related field: knowledge of the bio/pharm industry - Experience engaging in regulatory and safety policy development and implementation - Leading at a functional level and working in a global matrix environment - Experience working in a global environment Competencies: - Leadership skills - Conflict management - Managing diversity - Listening - Managing and measuring work - Building effective teams - Problem solving - Ability to keep the big picture" in mind while dealing with the details - Ability to envision and implement business process solutions - Good written and verbal communication sills - Relationship building skills2012-04-02 23:24:51United StatesAmgenCalifornia14575BRCAThousand Oaks, CA27593239http://www.amgen.jobs/xml/27593239/jobUSAThousand OaksAuto req 14589BR Job Posting Title Regulatory Writing Sr Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The purpose of this group is to prepare scientific and regulatory documents that comply with global regulatory standards. This position could be located in Thousand Oaks California, South San Francisco California, or at a remote home office. Job Summary: Prepare and oversee the development of scientific and regulatory documents and oversee senior management approval of these documents. Serve as functional area lead on product teams. Train and mentor medical writers and manage the work of GRW staff. Assist with hiring and departmental governance and with resourcing therapeutic areas and project teams. Key Activities: - Independently write clinical study reports, Investigator Brochures, Summaries of Clinical Efficacy, Summaries of Clinical Safety, Summaries of Clinical Pharmacology, Summaries of Biopharmaceutics, Clinical Overviews, Tables of All Studies, briefing documents, Risk Management Plans, and Response to regulatory questions - Prepare and manage the development of other regulatory documents and CTD sections, as appropriate (Modules 2, 3, 4 and 5 for CTD, Risk Management Plans, Responses to regulatory agency questions, protocols, statistical analysis plans, FIH documents) - Formally review and approve all regulatory documents - Serve as the functional area representative and lead on product teams (ie, GDT, GCST, GRT) - Provide functional area input for Global Regulatory Plans, Global Development Plans, and team goals - Responsible for study timelines for regulatory documents - Participate in development of regulatory submission strategy - Manage medical writers (includes career development, conducting performance reviews, providing coaching and guidance) - Identify, assess, and oversee individual contractors, freelance, and temporary writers - Keep abreast of professional information and technology through literature, symposia, and conferences - Participate in departmental and cross-departmental initiatives - Provide innovation for improving departmental processes - Provide expertise and guidance on document design and principles of good medical writing to the department and product teams - Work with medical writers to establish project priorities - Oversee all decisions made by reports - Assist with budget Basic Knowledge and Skills: - Experience reading, understanding, and applying regulations to constantly changing - Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment - Experience understanding and interpreting data/information and its practical application - Excellent written/oral communication skills and attention to detail - Strong time and project management skills - Negotiating skills - Perseverance with a drive for results Basic Qualifications - Doctorate degree and 2 years of directly related experience OR - Master's degree and 6 years of directly related experience OR - Bachelor's degree and 8 years of directly related experience OR - Associate’s degree and 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - 8+ years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs) - Advanced knowledge of scientific/technical writing and editing - Advanced knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery - Understanding and application of principles, concepts, theories and standards of scientific/technical field - Knowledge of management skills and supervising the work of others - Understands the core business process and purpose of the functional area in Amgen's commercialization process - Strong Leadership in a team environment - Strong negotiator - Mentoring, training and directing others - Developing and delegating to direct reports with a drive for results2012-03-28 21:29:19United StatesAmgenCalifornia14589BRCAThousand Oaks, CA27464082http://www.amgen.jobs/xml/27464082/jobUSAThousand OaksAuto req 13841BR Job Posting Title Exec Dir Regulatory Affairs - Bone TA Career Category Regulatory Employee Subgroup Executive FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description This role leads the Bone Therapeutic Area team within Amgen's Regulatory Affairs department. The Therapeutic Area Head (TAH) manages a team responsible for developing and executing regulatory strategies and managing effective regulatory agency interactions to achieve desired regional labeling and global registration. The TA Head will represent Global Regulatory Affairs as a member of the Therapeutic Area Steering Committee (TASC) within the Amgen Commercialization Process in addition to providing high-level strategic guidance to Global Regulatory Leaders. Key Activities: • Consult with Global Regulatory Leaders (GRL) in development of global regulatory strategies and approve Global Regulatory Plan and Global Strategic Plan • Global oversight of all regulatory aspects between and across products within a therapeutic area • In collaboration with Amgen regional staff, interact and negotiate with key regulatory agency officials in the execution of Global Strategic Plans • Oversee core regulatory and cross-functional teams to ensure effective agency interactions • Provide technical expertise in inspections, negotiate the need for inspections, review responses to observations • Provide input to TASC, senior management review committees, governance boards, other cross-functional product meetings • Provide guidance to team on regulatory strategies, precedence and risk management • Consult and review contingency planning/risk assessment for products within a therapeutic area development strategies and agency interactions • Monitor, assess and communicate impact of relevant global regulations, guidance’s current regulatory environment and competitor labeling • Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs • Provide coaching, mentoring, and development of staff Basic Qualifications • Doctorate degree and 6 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies OR • Master’s degree and 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies OR • Bachelor’s degree and 12 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, FDA, or other international regulatory agencies AND • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources Preferred Qualifications • Advanced degree • Regulatory submissions experience specific to bone products • Experience interacting with senior regulatory agency representatives Knowledge and Skills leveraged in the role: • Strong communication skills – both oral and written • Ability to understand and communicate scientific/clinical information • Demonstrated ability to lead teams2012-02-11 19:45:48United StatesAmgenCalifornia13841BRCAThousand Oaks, CA26476662http://www.amgen.jobs/xml/26476662/jobUSAThousand OaksAuto req 13582BR Job Posting Title Regulatory Affairs Sr Mgr (GRAAS Biosimilars-CMC) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. - Coordination of global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans - Development of CMC and analytical dossiers required for registration of biosimilar products - Management of long term CMC planning and regulatory CMC submissions for licensed products Key Activities: Regulatory Strategy and Filing - Provide expertise in the development, communication, and implementation of global CMC regulatory strategies in support of Biosimilars Operating Unit’s goals and product portfolio execution - Ensure regulatory documents (including analytical similarity packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents as required) are developed with high quality and delivered in a timely manner - Lead cross-functional teams in development and submission of Quality documents, including responses to questions from regulatory authorities - Maintain product licenses per regulatory requirements and updated according to long-term plans - Support development and execution of clinical and non-clinical plans - Develop and deliver analytical similarity packages that meet biosimilar regulatory requirements, as directed by the RA CMC Lead - Deliver CMC information for submissions (including Module 3, analytical similarity assessments) - Prepare for and participate in CMC-related agency interactions - Represent RA CMC on the TOST and TOET - Provide CMC functional support for Amgen Biosimilars Operating Unit - Collaborate with other GRAAS functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices) - Comply with critical GRAAS CMC processes Regulatory Intelligence - Monitor, assess and implement regional CMC regulatory requirements - Review and assess CMC impact of health authority decisions for competitive products - Generate and communicate CMC intelligence to the Amgen Biosimilars Operating Unit Collaboration - Participate in vendor oversight and management for regulatory CMC operations, as required - Provide regulatory risk assessment to the GRAAS Biosimilars function and to CMC filing teams - Identify process needs to meet internal challenges - Escalate CMC issues, progress, and metrics to the GRAAS Biosimilars function - Represent Biosimilars Regulatory Affairs CMC on committees, as necessary Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - CMC-specific regulatory knowledge and experience - Ability to understand and communicate scientific information - Ability to anticipate and prevent potential issues - Ability to communicate regulatory requirements to ensure expectations are understood - Industry experience in manufacture, testing (QC/QA), or distribution - Global regulatory CMC knowledge and experience - Regulatory submissions experience - Working with policies, procedures and SOPs - Experience in analytical similarity or comparability assessments and development of associated packages2012-01-25 21:04:52United StatesAmgenCalifornia13582BRCAThousand Oaks, CA26111472http://www.amgen.jobs/xml/26111472/jobUSAThousand OaksAuto req 13567BR Job Posting Title Regulatory Affairs Sr Mgr (GRAAS Biosimilars) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description Group Purpose: To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. Job Summary: - Coordination of global regulatory activities relevant to the successful execution and implementation of biosimilar regulatory affairs strategies and plans - Development of regulatory dossiers and briefing documents required for clinical trials and registration of biosimilar products - Ensure compliance with regulatory requirements to support ongoing clinical trials - Ensure compliance with regulatory requirements for licensed products Key Activities: Regulatory Strategy and Execution - Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, MAs, and Responses to Questions for products within the biosimilars portfolio in compliance with approved filing plans, timelines, and regulatory requirements - Provide regulatory direction on regional regulatory requirements to optimize product development timelines - Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning - Support development and execution of clinical/ non-clinical strategies - Provide review, input, and regulatory advice into study concept documents, study protocols, informed consent forms, statistical analysis plans, clinical study reports and related regulatory documents used to support product development and registration - Participate and collaborate with labelling teams on the development of global product labels and core data sheets to align commercial objectives with expected regulatory guidance and precedent - Collaborate with Amgen affiliates as required to ensure effective implementation of global regulatory strategies and plans - With minimal supervision, participate in development of risk management and contingency planning - Ensure and lead regulatory compliance for biosimilar products (eg, PMCs and other agency commitments) Regulatory Intelligence - Monitor, assess and implement regional regulatory requirements, guidelines, and policies relating to biosimilar products - Review and assess impact of regulatory decisions for competitive products - Generate and communicate biosimilar intelligence Collaboration - Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products - Contribute to appropriate, and participate in, vendor oversight and management for regulatory and safety operations - Identify process needs to meet internal challenges - Escalate regulatory issues, progress, and metrics to the GRAAS Biosimilars function - Represent Biosimilars Regulatory Affairs on committees, as necessary Knowledge and Skills - Comprehensive understanding of Regulatory and Safety functional activities and how they affect projects and processes - Regulatory experience with product filings - Ability to understand and communicate scientific and clinical information - Ability to anticipate and prevent potential issues - Ability to communicate regulatory strategies and requirements to ensure expectations are understood - Cultural awareness and sensitivity to achieve results across different regions Basic Qualifications - Doctorate degree & 2 years of directly related experience OR - Master’s degree & 6 years of directly related experience OR - Bachelor’s degree & 8 years of directly related experience OR - Associate’s degree & 10 years of directly related experience OR - High school diploma / GED & 12 years of directly related experience Preferred Qualifications - RAC - Regulatory knowledge of global regulations - Regulatory submissions experience - Working with policies, procedures and SOPs - Interacting with regulatory agency representatives - Understanding of drug development2012-01-25 21:04:29United StatesAmgenCalifornia13567BRCAThousand Oaks, CA26111457http://www.amgen.jobs/xml/26111457/jobUSAThousand OaksAuto req 12650BR Job Posting Title Regulatory Affairs Sr Mgr (device) Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The RA CMC Group is responsible for generation of the global regulatory strategy and providing feedback to the team for plans and execution of the strategy. Facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Job Summary: Develop and implement regulatory strategies to support both new and existing combination products and innovative delivery devices. Key Activities: • Provide strategic expertise regarding regulatory requirements for drug delivery device related projects • Interface with Regulatory Authorities as appropriate • Work in conjunction with Global RA product leads and Regional RA representatives • Serve as Regulatory Affairs representative on Cross Functional Teams regarding drug delivery devices • Support Regulatory Filings and provide team guidance regarding: o US 510(k) filings o CE Mark requirements o Device quality management system requirements o ISO requirements o Clinical requirements for drug delivery devices o Device registration maintenance including Registration renewals o Complaints and Recalls • Review and approve selected regulatory documents • Represent Regulatory Affairs to outside departments, product teams and regulatory agencies • Represent Amgen at external events (PhRMA, PDA, ISPE, BIO, etc.), as appropriate • Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts • Serve as the primary resource within the RA-CMC team to support drug/device combination products or other drug delivery device projects Basic Qualifications • Doctorate degree and 2+ years of directly related experience OR • Master’s degree and 6+ years of directly related experience OR • Bachelor’s degree and 8+ years of directly related experience OR • Associate’s degree and 10+ years of directly related experience OR • High school diploma / GED and 12+ years of directly related experience Preferred Qualifications - Degree in Life Sciences, Engineering or related field - 7+ years of related experience in the pharmaceutical/biotechnology or medical device industry - 5+ years experience in Regulatory Affairs - Regulatory experience with Drug/Device combination products or drug delivery device product filings a requirement - Ability to work within a matrix team environment - Able to operate in a fast paced, dynamic environment - Able to manage and execute activities to meet agreed upon timelines - Strong oral and written communication skills - Strong negotiating and leadership skills - International experience – preferred2011-11-03 23:36:13United StatesAmgenCalifornia12650BRCAThousand Oaks, CA24581799http://www.amgen.jobs/xml/24581799/job