Regulatory Affair Director - Global Regulatory Leader (Rare Disease)
Amgen
June 27, 2026
Remote friendly (United States)
United States
Corporate Functions
Regulatory Affair Director - Global Regulatory Leader (Rare Disease)
Responsibilities:
- Develop Global Regulatory Strategic Plan and provide regulatory input to the Global Strategic Plan.
- Represent GRA on Product Team (PT) and Evidence Generation Team (EGT) to support product registration strategies, regulatory approval, and labeling.
- Provide regulatory direction for the core data sheet; lead development, review, and approval of the target product label (TPL).
- Obtain input from GRT members to develop global regulatory strategy supporting development, registration, and lifecycle maintenance.
- Lead global regulatory filings (e.g., clinical trial applications, marketing applications, label extensions, CMC changes).
- Ensure consistency of evidence-based global product communication; conduct contingency regulatory planning/risk assessment.
- Monitor global regulations/guidances and incorporate mechanisms to optimize development (e.g., Orphan Drug Designation, Breakthrough Therapy/PRIME, Fast Track, conditional/accelerated approval, compassionate use, pediatric plan).
- Lead global health authority interactions; ensure effective communications and attend key agency meetings.
- Lead and coach/mentor GRT; integrate regional input; align global cross-functional goals.
- Represent Global Regulatory Affairs on commercialization teams; provide education/training on regulatory strategies and compliance.
- Advocate externally with senior agencies and professional bodies; influence legislative environment; conduct regulatory due diligence for licensing/acquisition opportunities (as assigned).
Qualifications:
- Doctorate with 4 years directly related experience OR Master’s with 8 years OR Bachelor’s with 10 years.
- Plus at least 4 years experience directly managing people and/or leading teams/projects/programs/resources.
Preferred Skills:
- Team leadership; strong oral/written communication; ability to understand scientific/clinical information.
- Understanding of regulatory activities; anticipate/mitigate uncertainties.
- Conflict resolution, influencing/negotiation skills; cultural awareness across regions/international borders.
Benefits:
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending); discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application instructions:
- Apply at careers.amgen.com; anticipated application acceptance until 6/25/26 (may continue if needed). Sponsorship not guaranteed.
Responsibilities:
- Develop Global Regulatory Strategic Plan and provide regulatory input to the Global Strategic Plan.
- Represent GRA on Product Team (PT) and Evidence Generation Team (EGT) to support product registration strategies, regulatory approval, and labeling.
- Provide regulatory direction for the core data sheet; lead development, review, and approval of the target product label (TPL).
- Obtain input from GRT members to develop global regulatory strategy supporting development, registration, and lifecycle maintenance.
- Lead global regulatory filings (e.g., clinical trial applications, marketing applications, label extensions, CMC changes).
- Ensure consistency of evidence-based global product communication; conduct contingency regulatory planning/risk assessment.
- Monitor global regulations/guidances and incorporate mechanisms to optimize development (e.g., Orphan Drug Designation, Breakthrough Therapy/PRIME, Fast Track, conditional/accelerated approval, compassionate use, pediatric plan).
- Lead global health authority interactions; ensure effective communications and attend key agency meetings.
- Lead and coach/mentor GRT; integrate regional input; align global cross-functional goals.
- Represent Global Regulatory Affairs on commercialization teams; provide education/training on regulatory strategies and compliance.
- Advocate externally with senior agencies and professional bodies; influence legislative environment; conduct regulatory due diligence for licensing/acquisition opportunities (as assigned).
Qualifications:
- Doctorate with 4 years directly related experience OR Master’s with 8 years OR Bachelor’s with 10 years.
- Plus at least 4 years experience directly managing people and/or leading teams/projects/programs/resources.
Preferred Skills:
- Team leadership; strong oral/written communication; ability to understand scientific/clinical information.
- Understanding of regulatory activities; anticipate/mitigate uncertainties.
- Conflict resolution, influencing/negotiation skills; cultural awareness across regions/international borders.
Benefits:
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending); discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application instructions:
- Apply at careers.amgen.com; anticipated application acceptance until 6/25/26 (may continue if needed). Sponsorship not guaranteed.