U.S. Regulatory Strategy – Obesity and Related Conditions, Senior Manager
Amgen
July 02, 2026
Remote friendly (United States)
United States
Corporate Functions
U.S. Regulatory Strategy – Obesity and Related Conditions, Senior Manager
Responsibilities:
- Develop and refine global regulatory strategy with U.S.-specific insights for obesity/metabolic conditions.
- Apply scientific expertise to inform regulatory strategy (endpoints, long-term safety).
- Partner with Global Regulatory Lead (GRL) to align global timelines, core documents, and regulatory positioning.
- Execute U.S. regulatory strategy for assigned programs; represent U.S. on global governance teams.
- Plan and lead U.S. regulatory submissions (clinical trial and marketing applications) per global filing plans.
- Lead key regulatory documents (labels, briefing packages, submission components).
- Drive U.S. labeling strategy with the Labeling Working Group (negotiation, timelines, deviation/waiver decisions).
- Provide input on U.S. development pathways (expedited programs, orphan designation, pediatric strategy).
- Lead Health Authority interactions; manage RTQs/agency feedback via cross-functional coordination.
- Assess regulatory risk and communicate contingencies; ensure compliance with commitments/obligations/records.
- Monitor regulatory intelligence; partner with Clinical, Medical, Safety, and Commercial.
- Lead and develop staff (prioritization, coaching, resource planning).
Qualifications:
Basic: Doctorate + 2 yrs; or Master’s + 6 yrs; or Bachelor’s + 8 yrs; or Associate’s + 10 yrs; or HS/GED + 12 yrs directly related. Minimum 2 yrs people management and/or leadership experience.
Preferred: Obesity/metabolic/endocrinology regulatory strategy; strong obesity/metabolic science and endpoints knowledge; U.S. labeling strategy experience; strong communication/influencing; global/regulatory experience outside U.S.; experience with regulated SOPs/policies.
Benefits (as stated): Total Rewards Plan including health/welfare plans, retirement/savings, work/life balance, career development; comprehensive benefits (medical/dental/vision, life/disability, flexible spending), annual bonus/incentive, stock-based long-term incentives, time-off, and flexible work models where possible.
Application instructions: Apply via careers.amgen.com. No application deadline; applications accepted until sufficient number or candidate selected. Sponsorship not guaranteed.
Responsibilities:
- Develop and refine global regulatory strategy with U.S.-specific insights for obesity/metabolic conditions.
- Apply scientific expertise to inform regulatory strategy (endpoints, long-term safety).
- Partner with Global Regulatory Lead (GRL) to align global timelines, core documents, and regulatory positioning.
- Execute U.S. regulatory strategy for assigned programs; represent U.S. on global governance teams.
- Plan and lead U.S. regulatory submissions (clinical trial and marketing applications) per global filing plans.
- Lead key regulatory documents (labels, briefing packages, submission components).
- Drive U.S. labeling strategy with the Labeling Working Group (negotiation, timelines, deviation/waiver decisions).
- Provide input on U.S. development pathways (expedited programs, orphan designation, pediatric strategy).
- Lead Health Authority interactions; manage RTQs/agency feedback via cross-functional coordination.
- Assess regulatory risk and communicate contingencies; ensure compliance with commitments/obligations/records.
- Monitor regulatory intelligence; partner with Clinical, Medical, Safety, and Commercial.
- Lead and develop staff (prioritization, coaching, resource planning).
Qualifications:
Basic: Doctorate + 2 yrs; or Master’s + 6 yrs; or Bachelor’s + 8 yrs; or Associate’s + 10 yrs; or HS/GED + 12 yrs directly related. Minimum 2 yrs people management and/or leadership experience.
Preferred: Obesity/metabolic/endocrinology regulatory strategy; strong obesity/metabolic science and endpoints knowledge; U.S. labeling strategy experience; strong communication/influencing; global/regulatory experience outside U.S.; experience with regulated SOPs/policies.
Benefits (as stated): Total Rewards Plan including health/welfare plans, retirement/savings, work/life balance, career development; comprehensive benefits (medical/dental/vision, life/disability, flexible spending), annual bonus/incentive, stock-based long-term incentives, time-off, and flexible work models where possible.
Application instructions: Apply via careers.amgen.com. No application deadline; applications accepted until sufficient number or candidate selected. Sponsorship not guaranteed.