Global Regulatory Affairs Director - Oncology

Amgen; United States; Remote; USD 197,000 - 237,000; Full time

Job summary

A leading biotechnology company is seeking a Regulatory Affairs Director for its Oncology Therapeutic Area. This role involves leading global regulatory strategies, managing a team, and ensuring compliance with worldwide regulations. The ideal candidate will have a strong background in regulatory affairs, particularly in biotech, and possess excellent leadership and communication skills.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Qualifications

• 4 years of regulatory experience with Doctorate, or 8 years with Master’s, or 10 years with Bachelor’s.

Responsibilities

• Lead the Global Regulatory Team in product development and registration.
• Develop global regulatory strategies and ensure effective agency communications.

Skills

Leadership

Communication

Negotiation

Planning

Problem Solving

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Career Category Regulatory

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Regulatory Affairs Director - Global Regulatory Leader - Oncology

Live

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this vital, product-facing role, you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization. The purpose of Regulatory Affairs Director is:

• To lead a team within Amgen’s Global Regulatory Affairs department
• To develop a comprehensive regulatory strategy that considers worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
• To provide regulatory expertise and guidance to product teams

Key Responsibilities include:

• Develop and execute the global regulatory product strategy
• Lead Global Regulatory Teams
• Represent Global Regulatory Affairs on the Product Team and key commercialization governance bodies
• Develop Global Regulatory Strategic Plans and provide regulatory input into the product's Global Strategic Plan. Obtain input from GRT members to develop a global regulatory strategy supporting product development, registration, and lifecycle maintenance. Identify and communicate regulatory risks.
• Represent GRA on the product team
• Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
• Provide direction in the development of core datasheets to align commercial objectives with scientific data, regulatory guidance, and precedent
• Lead planning and implementation of global regulatory filings (e.g., clinical trial applications, marketing applications, label extensions, CMC changes)
• Ensure consistency of evidence-based global product communication (e.g., regulatory submission documents)
• Monitor and assess the impact of relevant global regulations, guidance, and current regulatory environment
• Ensure guidance on regulatory mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug, Fast Track, accelerated approval, compassionate use, pediatric plans) is incorporated into the global regulatory strategy
• Communicate well-defined, successful regulatory strategies throughout the organization to ensure expectations are understood
• Ensure effective agency communications by leading core regulatory and cross-functional teams (e.g., GRTs, filing teams)
• Attend key regulatory agency meetings impacting global product strategy
• Represent Amgen Regulatory on external partnership teams at the product level

Win

What we expect of you

We all bring unique contributions to serve patients. The ideal candidate is a leader with these qualifications:

Basic Qualifications:

• Doctorate degree with 4 years of regulatory experience in biotech or science, OR
• Master’s degree with 8 years of regulatory experience in biotech or science, OR
• Bachelor’s degree with 10 years of regulatory experience in biotech or science

Preferred Qualifications:

• Supervisory experience preferred
• Contemporary oncology experience desired
• Ability to lead and build effective teams
• Strong communication skills – both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and mitigate future strategic issues & uncertainties
• Conflict resolution skills and developing courses of action
• Cultural awareness and sensitivity for global results
• Planning and organizational abilities
• Prioritization and multitasking skills
• Decision-making and problem-solving skills
• Comfort with ambiguity
• Organizational savvy
• Negotiation skills

Thrive

What you can expect from us

We support our team members’ professional and personal growth and well-being, offering:

• Comprehensive benefits including health, dental, vision, life, and disability insurance, and flexible spending accounts
• Discretionary annual bonus or sales-based incentives for field reps
• Stock-based long-term incentives
• Award-winning time-off policies and bi-annual shutdowns
• Flexible work arrangements, including remote options where possible

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

We accept applications until we find a suitable candidate.

careers.amgen.com

Amgen is an Equal Opportunity employer and considers all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are provided for individuals with disabilities.

Salary Range

197,095.00 USD - 236,022.00 USD