Instagram
youtube
Facebook

Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular)

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 united by our mission to serve patients living with serious illnesses. Since 1980, we’ve pioneered advancements in biotech to fight some of the world’s most challenging diseases. Focused on Oncology, Inflammation, General Medicine, and Rare Diseases, we reach millions of patients globally. By joining the Amgen team, you’ll help transform the lives of patients through innovative medicines that enable people to live longer, fuller lives.

Position: Regulatory Affairs Director - Global Regulatory Lead (General Medicine/Cardiovascular)
Location: Global

What You Will Do

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

Key Responsibilities

  • Develop and execute the global regulatory product strategy.
  • Lead GRTs within the Global Regulatory Affairs organization.
  • Represent Regulatory Affairs in product teams and governance bodies.
  • Develop strategies for global registration, labeling, and regulatory agency interactions.
  • Guide product teams in regulatory decisions, including clinical trials, marketing applications, and label extensions.
  • Manage global regulatory filings and ensure effective communication across teams.

What We Expect From You

We seek a leader with:

  • Basic Qualifications:

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

    • Proven ability to lead teams and resolve conflicts.
    • Strong communication skills, both oral and written.
    • Experience in regulatory affairs for biological products and in early and late-stage development.

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 arrangements, including remote/hybrid options.
  • Career development opportunities to help you grow in your career.

Apply Now

Join Amgen and make a lasting impact on patients' lives while advancing 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.