Amgen Sr Associate Regulatory Affairs in Thousand Oaks, California
Amgen is searching for a Senior Associate Regulatory Affairs to work in our Global Regulatory Affairs group. The Senior Associate Regulatory Affairs will report to Senior Manager Regulatory Affairs and will work out of our main corporate campus in Thousand Oaks, CA.
The Regulatory Affairs Chemistry Manufacturing and Controls (RA CMC) team located in Thousand Oaks is responsible for providing insights and deliverables to the product teams and site for generation of the product strategy and plans and for execution. The Senior Associate Regulatory Affairs will interface with the Amgen Global and Regional CMC Regulatory leads, site teams and supply chain for specific strategies or activities that impact a product or multiple products.
The Senior Associate Regulatory Affairs is accountable for deliverables that ensure Amgen corporate and Thousand Oaks site operations including State Licensing, distribution reports, annual reports and annual product reviews. The Senior Associate Regulatory will be responsible for varying levels of product support, including leading projects, based upon their experience level.
The Senior Associate of Regulatory Affairs is responsible for:
Regulatory assessments of change control requests for clinical and commercial molecules.
Contributions to Amgen Thousand Oaks site inspections: provides and may present Amgen corporate/ portfolio information and regulatory role within change control.
Contributions to the organization and preparation of CMC sections of IND annual reports and annual reports of minor changes for specific products to meet the strategy defined by the global CMC team.
Documenting CMC submissions and related communications in IMR; archiving documents in document management systems.
Training staff on select CMC procedures and systems.
Interfacing with regulatory operations staff.
Contributions to CMC product teams: interacts with authors/reviewers with respect to delivery of documents required for regulatory submissions; provides report status of activities and projects to teams and department.
Possible participation in cross-functional special project teams.
Contributions to the design and content development of department training programs.
Contributions to the timely and accurate submission of license applications: Tracking and organization of documentation including maintenance and optimization of licensing database, EDMQ/EPIC document management, maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses, generating license reports as needed for Management or Business Integration activities, working with extended Amgen Licensing Network including obtaining Corporate Officer approvals, arranging notarization as needed. May interact with Licensing consultants.
Basic Education and Experience:
Bachelor's degree and 2 years of Pharmaceutical/Biotechnology industry experience
Associate's degree and 6 years of Pharmaceutical/Biotechnology industry experience
High school diploma / GED and 8 years of Pharmaceutical/Biotechnology industry experience
Preferred Education and Experience:
Degree in Life Science discipline
5-7 years experience in manufacturing, testing (QC/QA or clinical), or distribution Pharmaceutical/Biotechnology industry; 3-5 years regulatory CMC specific regulatory knowledge & experience
State wholesale and distributor license renewal procedures
Understanding and application of principles, concepts, theories and standards of scientific/technical field
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.