Amgen Regional Regulatory Affairs Lead - Senior Manager in Cambridge, United Kingdom
Regional Regulatory Lead -Senior Manager
Amgen Regulatory General Medicine Team are looking for a regulatory professional to support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
If you are looking for your next career step within a Regional Regulatory role and want to be part of our mission - To serve patients - which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK https://careers.amgen.com/where-we-are/en-gb/
Our Regulatory Regional General Medicine Team:
The Europe General Medicine Regulatory Therapeutic Area team are part of the Global Regulatory Affairs function in Europe, and are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
The General Medicine regulatory team are leading the regulatory activities for products such as Repatha, Prolia, Parsabiv and also development assets in the Metabolic, Cardiology, Inflammation, Endocrine, Bone and Neuroscience disease areas, as well as pre-approval filing activities for Biosimilars. The General Medicine team collaborate closely with global, regional and local cross functional teams to deliver optimal regional regulatory outcomes for Amgen.
Regional Regulatory Lead - Senior Manager role overview:
To ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Representing the region, this role is responsible for advising the GRT on regional considerations in developing strategy and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
As well as ensuring regulatory compliance, with a focus on patient safety, as requested, this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade).
Strategy and Execution
Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Leads development of regional regulatory documents and meetings in accordance with GRT strategy
Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Manages regional label negotiation activities
With minimal supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
Communicates regulatory strategies as appropriate such that expectations are understood.
Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line Management
Develop predictions for expectations and risks associated with outcomes by regulatory agencies
Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
Share regulatory information and implications with the GRT colleagues on an ongoing basis and provide advice on regional considerations
Communicate and ensure alignment of regional management before GRT strategy decisions
Partner with regional management and peers to ensure consistency in procedures and agency interactions
Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling
Health Authority Interactions
Act as contact and create relationships with agency staff on specific product assignment
Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management
Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
Region Specific Activities
US: Advises and supports promotion group regarding applicability of data for product communication in the US
EU: Review and approve promotional and non-promotional materials for use in international region
APAC, LACAN, EEMEA: Lead the product lifecycle for individual countries per national agency requirements
APAC, LACAN, EEMEA: Work through the regional leads to manage distributor markets
Supports communication/collaboration between direct reports who are regional leads and regional head for program issues requiring next level engagement
Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
Qualifications and required experience:
Regulatory knowledge in national regulations
Working with policies, procedures and SOP's
Experience with national legislation and regulations relating to medicinal products
Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
Understanding of drug development
Proven experience and skills needed:
Good communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues
Communication of regulatory strategies such that expectations are understood.
Anticipate regulatory agency responses to strategy
Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
About our company:
Amgen is one of the world's largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.