Amgen
Global Regulatory Affairs Director - Inflammation and Rare Disease
United States - Remote · Director
Sponsorship not specifiedDetected 8 hours ago
Product StrategyNegotiationFDA RegulatoryResearchLeadershipCommunicationRegulatory Affairs
About the role
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
- With our 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 and obesity-related conditions.
Responsibilities
- Develop and execute the global regulatory product strategy
- 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.
- Develop registration strategies and plans aimed at achieving regulatory approval and product labeling
- 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)
- 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
- In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
- The role of the Regulatory Affairs Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions, and to provide regulatory expertise and guidance to product teams.
Requirements
- 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
Nice to have
- 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
- Cultural awareness and sensitivity to achieve global results
- Planning and organizing abilities
- Ability to make complex decisions and solve problems
- Ability to deal with ambiguity
- Negotiation skills
Compensation
- 189,632.45USD -256,561.55 USD
Company info
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
- Please contact us to request accommodation.
- We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.