Global Regulatory Affairs Director - Inflammation and Rare Disease
Amgen
Summary
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) in the Regulatory Affairs organization.
Job description
Key Responsibilities
- Develop and execute the global regulatory product strategy
- Lead GRTs
- Represent Regulatory on the product team and other key commercialization governance bodies
- Develop Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan
- Obtain input from the GRT members to develop a global regulatory strategy which supports 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 regulatory direction in the development of the core data sheet to align commercial objectives in the context of 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 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, conditional/accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy
- Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood
- Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
- Attend key regulatory agency meetings which could impact the global product strategy
- Represent Amgen Regulatory on external partnership teams at the product level
Basic Qualifications
- Doctorate degree and 4 years of regulatory experience in biotech or science
- Or Master's degree and 7 years of regulatory experience in biotech or science
- Or 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 against future strategic issues & 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
Requirements
- Doctorate degree and 4 years of regulatory experience in biotech or science
- Or Master's degree and 7 years of regulatory experience in biotech or science
- Or Bachelor's degree and 9 years of regulatory experience in biotech or science
- 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 against future strategic issues & 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
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Annual bonus program
- Stock-based long-term incentives
- Paid time off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.