Regulatory Affairs Associate Director

Role description:

Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization.

The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgens GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintain compliance with global registrations, maintain labeling, oversee effective regulatory agency interactions, and provide regulatory expertise and guidance to product teams.

Key Responsibilities:

1) Develop and execute the global regulatory product strategy

2) Lead GRTs

3) Represent Regulatory on the product team and other key cross-functional teams and commercialization governance bodies

4) Obtain input from the GRT members to develop a global regulatory strategy which supports lifecycle maintenance.

5) Identify and communicate regulatory risks

6) Develop strategies and plans to maintain regulatory approvals and product labeling

7) Provide regulatory direction in the development of the core data sheet in the context of available and expected scientific data, regulatory guidance and precedent

8) Lead the planning and implementation of global regulatory filings (e.g. label extensions, CMC changes)

9) Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)

10) Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

11) Ensure guidance on regulatory mechanisms to optimize lifecycle management is assessed and incorporated into the global regulatory strategy

12) Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood

13) Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)

14) Attend key regulatory agency meetings which could impact the global product strategy

15) Represent Amgen Regulatory on external partnership teams at the product level

Basic Qualifications and Experience:

• We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
• Doctorate degree and 3 years of regulatory experience in biotech or science Or
• Masters degree and 6 years of regulatory experience in biotech or science Or
• Bachelors degree and 8 years of regulatory experience in biotech or science

Soft Skills

• Ability to lead effective teams
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and mitigate against future issues & uncertainties
• Ability to resolve conflicts and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and manage multiple activities
• Ability to make decisions and solve problems
• Ability to deal with ambiguity