Instagram
youtube
Facebook

Regulatory Affairs Senior Manager – Regional Regulatory Lead

10-12 years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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, our shared mission is to serve patients—and we are one of the world’s leading biotechnology companies because of it. We research, manufacture, and deliver products that improve the lives of over 10 million patients globally. If you’re ready for a career that combines challenges with incredible opportunities, now is the time to join us.


Regulatory Affairs Senior Manager – Regional Regulatory Lead

In this vital role, you will ensure regulatory compliance with all applicable laws and regulations, while driving Amgen’s US regulatory strategy to support product development and approval. You will collaborate with cross-functional teams, manage regulatory submissions, and maintain key relationships with regulatory agencies like the FDA.

What You Will Do

As a Regulatory Affairs Senior Manager, you will:

  • Implement US Regulatory Plans: Ensure successful approvals of Clinical Trial Authorizations and Marketing Applications in the US.
  • Develop US Regulatory Strategies: Guide and optimize product development via regulatory mechanisms such as orphan drug status, fast track, early access, and pediatric plans.
  • Collaborate Cross-Functionally: Partner with GRT and regional management teams to ensure regulatory alignment and address regional considerations.
  • Engage with Regulatory Agencies: Serve as a key contact at the FDA for product-related issues, ensuring effective communication and decision-making.
  • Maintain Compliance and Product Labeling: Lead the development and maintenance of US product labeling, working with cross-functional teams and regulatory agencies.
  • Conduct Regulatory Research: Stay up-to-date on developing legislation and guidance to predict the impact on product strategies and advance regulatory filings.

What We Expect of You

We are seeking a dynamic leader with:

Basic Qualifications

  • Doctorate degree and 2 years of regulatory or pharmaceutical drug development experience, or
  • Master’s degree and 4 years of experience, or
  • Bachelor’s degree and 6 years of experience, or
  • Associate’s degree and 10 years of experience, or
  • High school diploma / GED and 12 years of experience.

Preferred Qualifications

  • Experience with regulatory submissions (e.g., INDs, CTAs).
  • Interaction experience with regulatory agencies.
  • In-depth knowledge of national regulations and drug development processes.
  • Strong communication skills (both written and oral) and the ability to understand complex scientific information.
  • Team collaboration and problem-solving abilities in a diverse, global environment.

What You Can Expect of Us

At Amgen, we believe in taking care of our teammates as much as we do our patients. We offer:

  • Comprehensive Benefits Package: Including medical, dental, vision coverage, life and disability insurance, and flexible spending accounts.
  • Retirement and Savings Plan: Generous contributions to help you save for the future.
  • Work-Life Balance: Flexible work models, including remote options where possible.
  • Career Development: Access to learning and career growth opportunities.
  • Annual Bonus Program: Based on performance, with additional stock-based incentives.
  • Time-Off Plans: Award-winning vacation policies and bi-annual company-wide shutdowns.

Join Us.

At Amgen, we don’t just make medicines. We defy imagination by pushing the boundaries of what’s possible. Change the world with us.

Apply today at careers.amgen.com.

Amgen is an Equal Opportunity Employer. We provide accommodations for individuals with disabilities during the application and interview process.