Career Category

Regulatory

Job Description

Amgen is seeking a Regulatory Affairs, Sr. Manager to join our team and work from Amgen’s beautiful Thousand Oaks, CA campus. To learn more:  

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 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

Responsible for:
•Management of regulatory CMC and analytical requirements to ensure the development, regulatory approvals, and maintenance of product licenses for the biosimilar product portfolio
•Coordination of CMC activities and deliverables required by the GRAAS biosimilars function, including contributions provided by other Amgen and GRAAS functions
•Provision of guidance and insight to the successful execution and implementation of CMC regulatory strategies
•Collaboration with Amgen partners to develop and execute regional CMC regulatory activities
•Implement other activities as required by the Regulatory Affairs CMC Lead

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 Product Team and Global Operations Team
•Provide CMC functional support for Amgen Biosimilars Operating Unit
•Collaborate with other GRAAS functions on biosimilar issues, (e.g., 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

Knowledge and Skills:

•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

Competencies:
•Planning and organizing abilities, including familiarity with project management processes
•Managing multiple activities
•Making complex decisions
•Problem solving abilities
•Setting priorities
•Team work
•Multi-disciplinary nature
•Dealing with ambiguity
•Action oriented
•Flexibility with day-to-day requirements
•Conflict management
•Strong oral and written communication skills
•Professional negotiation, collaboration and leadership skills
•Excellent interpersonal and organizational skills
•Ability to provide direction and support for team members

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 2 years of directly related experience

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation.  Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.  A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

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