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Regulatory Affairs Director - Global Regulatory Lead

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

Join Amgen’s Mission to Serve Patients

At Amgen, we are driven by our shared mission to serve patients living with serious illnesses. Since 1980, we have been pioneering the biotech industry in our fight against some of the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Diseases, we impact millions of lives annually.

As part of the Amgen team, you’ll help make a lasting difference by researching, manufacturing, and delivering innovative medicines that help people live longer, fuller, and happier lives.

Position: Regulatory Affairs Director - Global Regulatory Lead
Therapeutic Area: Obesity

What You Will Do

Amgen is seeking a Regulatory Affairs Director to lead the Global Regulatory Team (GRT) in the Obesity Therapeutic Area. This key leadership role in our Global Regulatory Affairs (GRA) team will focus on:

  • Developing and executing the global regulatory product strategy.
  • Leading GRTs and representing Regulatory Affairs on product teams.
  • Developing regulatory strategies for global product registration, lifecycle management, and labeling.
  • Ensuring compliance with regulatory guidelines and managing key regulatory filings.
  • Representing Amgen’s regulatory interests in external partnerships.

Key Responsibilities

  • Develop and execute comprehensive regulatory strategies.
  • Lead the Global Regulatory Team (GRT) and align product teams with regulatory needs.
  • Represent Regulatory Affairs in product teams, ensuring alignment with global regulatory goals.
  • Develop and implement global regulatory filings and provide regulatory guidance throughout the product lifecycle.
  • Lead regulatory agency interactions and manage global product communication.

What We Expect From You

We are looking for a leader with:

  • Basic Qualifications:

    • Doctorate with 4 years of regulatory experience in biotech/science
    • Master’s with 7 years of regulatory experience
    • Bachelor’s with 9 years of regulatory experience
  • Preferred Qualifications:

    • Strong leadership and team-building skills.
    • Excellent communication and problem-solving abilities.
    • Experience in global regulatory affairs, early and late-stage development, and biological products.
    • Negotiation and cultural sensitivity skills.

What You Can Expect From Us

Amgen offers competitive benefits, including:

  • Comprehensive health coverage, retirement savings plans, and flexible spending accounts.
  • Discretionary annual bonuses and stock-based long-term incentives.
  • Award-winning time-off plans and flexible work models (including remote/hybrid).
  • Career development opportunities with a focus on your growth.

Apply Now

Take the next step in your career and join a team that’s transforming the lives of patients while transforming your own career.
Apply at careers.amgen.com.


Equal Opportunity Employer
Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We ensure reasonable accommodation for individuals with disabilities during the application process.