Global Regulatory Affairs Director - Inflammation and Rare Disease

Join Amgen’s mission of serving patients. At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the biotech industry in the fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on patients’ lives through research, manufacturing, and delivering innovative medicines.

About the role

Amgen is seeking a Regulatory Affairs Director supporting products in the Inflammation and Rare Disease 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) to develop a comprehensive regulatory strategy accounting for worldwide requirements, drive product development, global registration, and maintenance of desired regional labeling, and provide regulatory expertise to product teams.

Responsibilities

• Develop and execute the global regulatory product strategy
• Lead Global Regulatory Teams (GRTs)
• Represent Regulatory on the product team and other key commercialization governance bodies
• Develop the Global Regulatory Strategic Plan 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
• Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
• Provide regulatory direction in the development of the core data sheet to align commercial objectives with available and expected scientific data, regulatory guidance, and precedent
• Lead the 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 the current regulatory environment
• Ensure guidance on regulatory mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans) is assessed and incorporated into the global regulatory strategy
• Communicate well-defined, successful regulatory strategies throughout the organization so expectations are understood
• Ensure effective regulatory agency communications by leading core regulatory and cross-functional teams (e.g., GRTs, filing teams)
• Attend key regulatory agency meetings that could impact the global product strategy
• Represent Amgen Regulatory on external partnership teams at the product level

Qualifications

Basic Qualifications

• Doctorate degree and 4 years of regulatory experience in biotech or science
• Master’s degree and 7 years of regulatory experience in biotech or science
• Bachelor’s degree and 9 years of regulatory experience in biotech or science

Preferred Qualifications

• 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 and uncertainties
• Ability to resolve conflicts and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and manage multiple activities
• Ability to make complex decisions and solve problems
• Ability to deal with ambiguity
• Negotiation skills

Benefits

Amgen supports your professional and personal growth with a competitive benefits package and collaborative culture. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted, with actual salary varying based on relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, which may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible