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Regulatory Affairs Director - Oncology

7+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

How Might You Defy Imagination?

At Amgen, we are united by our mission to serve patients, driving all that we do. Our vision has made us one of the world’s leading biotechnology companies. As global collaborators, we work together to research, manufacture, and deliver life-changing products that help over 10 million patients worldwide. Join us in a career you can be proud of.

Position: Regulatory Affairs Director - Global Regulatory Lead (Oncology)
Location: Global

What You Will Do

Amgen is seeking a Regulatory Affairs Director to support products in the Oncology Therapeutic Area. In this essential, product-facing role, you will lead the Global Regulatory Team (GRT) and provide global regulatory leadership to drive product development, registration, and lifecycle management.

Key Responsibilities

  • Develop and execute global regulatory strategies.
  • Lead Global Regulatory Teams (GRTs) within the regulatory organization.
  • Represent Regulatory Affairs on the product team and key governance bodies.
  • Develop Global Regulatory Strategic Plans and provide regulatory input into the product’s global strategy.
  • Oversee registration strategies for regulatory approval and product labeling.
  • Provide regulatory direction in developing core datasheets aligned with commercial objectives.
  • Lead global regulatory filings, such as clinical trial and marketing applications.
  • Communicate regulatory strategies and lead effective agency communications across teams.
  • Represent Amgen Regulatory on external partnership teams at the product level.

What We Expect From You

We seek a dynamic leader with:

  • Basic Qualifications:
    • Doctorate with 4 years of regulatory experience
    • Master’s with 8 years of regulatory experience
    • Bachelor’s with 10 years of regulatory experience
  • Preferred Qualifications:
    • Experience in Oncology
    • Strong leadership, communication, and negotiation skills
    • Ability to navigate complex decisions, ambiguity, and cross-functional teams
    • Organizational savvy and the ability to manage multiple priorities

What You Can Expect From Us

Amgen offers a comprehensive Total Rewards Plan, including:

  • Health and wellness plans, retirement savings, and generous company contributions.
  • Stock-based long-term incentives and a discretionary annual bonus.
  • Flexible work models, including remote work arrangements where possible.
  • Award-winning time-off plans, bi-annual company-wide shutdowns, and more.

Apply Now

Join Amgen and make a lasting impact on the lives of patients while transforming your career. Apply at careers.amgen.com.


Equal Opportunity Employer
Amgen is an Equal Opportunity employer, considering all qualified applicants regardless of race, religion, sex, gender identity, national origin, disability status, or any other basis protected by law.

Application Deadline
We will continue accepting applications until the position is filled.