Job Title: Regulatory Affairs Senior Manager – Regional Regulatory Lead
Location: United States (with flexible working arrangements available)
Contract Type: Full-time
At Amgen, we are committed to developing innovative therapies that change lives. Our Regulatory Affairs Senior Manager ensures that we remain compliant with regulations and laws while developing and implementing effective US regulatory strategies. This pivotal role will involve interacting with federal, state, and local regulatory agencies to facilitate the approval and compliance of Amgen's products.
As a Regulatory Affairs Senior Manager, you will manage a variety of responsibilities focused on obtaining and maintaining regulatory approvals for Amgen’s products. Key responsibilities include:
Regulatory Strategy Implementation:
Develop and implement US regulatory plans, ensuring that Clinical Trial Authorizations and Marketing Application approvals are obtained and maintained.
Regulatory Documents & Agency Interactions:
Prepare and coordinate regulatory documents and meetings in alignment with the Global Regulatory Team (GRT) strategy, responding to regulatory inquiries and contributing to discussions about regional regulatory considerations.
Regulatory Risk Management:
Evaluate regulatory risks, predict agency interactions, and provide guidance on regulatory mechanisms to optimize product development (e.g., orphan drug status, fast track, early access).
FDA Communication & Collaboration:
Serve as a point of contact with the FDA for product-specific inquiries, documenting and communicating the outcomes of interactions to internal teams and senior management.
Product Labeling & Compliance:
Collaborate with the Labeling Working Group to develop the US product label, ensuring compliance with regulatory guidance and precedents. Support label negotiations and provide input for promotional communications.
Regulatory Research & Intelligence:
Keep current on regulatory developments, ensuring all regulatory intelligence tools are up to date and relevant to product advancement in the US.
Cross-functional Teamwork:
Engage with cross-functional teams, including GRT, to ensure alignment and consistency in regulatory procedures and agency interactions.
We are looking for an experienced regulatory professional with a deep understanding of the regulatory environment and a passion for collaboration. The ideal candidate will have:
At Amgen, we not only work to develop treatments for patients but also care about the professional and personal growth of our team members. As part of our team, you’ll receive:
Comprehensive Benefits:
A generous Total Rewards Plan including health coverage, retirement savings, life and disability insurance, flexible spending accounts, and more.
Work-Life Balance:
Award-winning time-off plans, bi-annual company-wide shutdowns, and flexible work models, including remote work options.
Career Development Opportunities:
Support for continuous learning and career growth with ample opportunities for advancement.
Apply now to join a team that defies imagination and makes a difference every day in the lives of patients. Together, we will change the world.
Visit Amgen Careers to apply.
Amgen is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace. We encourage applicants from all backgrounds and will provide reasonable accommodations to support individuals with disabilities during the application and interview process.
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