Manager, United States Regulatory Strategy, Obesity and Related Conditions
Amgen
July 02, 2026
Remote friendly (United States)
United States
Corporate Functions
United States Regulatory Strategy, Obesity and Related Conditions, Manager
Responsibilities:
- Execute U.S. regulatory strategy and deliverables; represent region on global teams.
- Plan and manage U.S. regulatory submissions (clinical trial and marketing applications) aligned to global filing plans and U.S. requirements.
- Implement product-related regulatory tactics in accordance with U.S. legislation/regulations and internal standards.
- Provide content guidance for key U.S. regulatory documents/meetings (e.g., briefing content, submission components).
- Support U.S. labeling development with the Labeling Working Group (LWG), including scientific data incorporation and labeling negotiation.
- Provide regulatory guidance on U.S. mechanisms/pathways (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use).
- Obtain/maintain clinical trial authorizations and marketing application approvals; support Responses to Questions (RTQs) and agency feedback.
- Communicate strategy/expectations with teams and assess success likelihood, expectations, and risks.
- Ensure ongoing regulatory compliance (e.g., IMR accuracy, PMCs/commitments, pediatric/agency obligations); proactively escalate issues.
- Maintain U.S. regulatory intelligence; monitor guidance/legislation and assess potential impact.
- Support Health Authority interactions; document outcomes and contribute to risk/contingency planning.
- Partner with cross-functional teams for alignment/execution, including U.S.-specific data use in communications (as applicable).
Basic Qualifications:
- Doctorate degree OR Master’s + 3 years OR Bachelor’s + 5 years OR Associate’s + 10 years OR High school/GED + 12 years, directly related.
- Experience directly managing people and/or leading teams/projects and directing resource allocation.
Preferred Qualifications:
- FDA regulatory submissions and agency interaction experience.
- Knowledge of U.S. legislation/regulations for medicinal products.
- Drug development and U.S. registration pathway knowledge (marketing applications, post-approval changes, extensions/renewals).
- Obesity/metabolic/endocrinology therapeutic area regulatory strategy experience.
- Scientific understanding of obesity/metabolic disease; knowledge of biological pathways and clinical endpoints.
- Labeling development and cross-functional collaboration (e.g., LWG).
- Strong written/oral communication.
- Risk anticipation and contingency planning.
- Conflict resolution; influence without authority; drive alignment.
- Ability to operate across global/regional teams.
Benefits:
- Comprehensive employee benefits package including Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; award-winning time-off; flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or a candidate is selected. Sponsorship not guaranteed.
Responsibilities:
- Execute U.S. regulatory strategy and deliverables; represent region on global teams.
- Plan and manage U.S. regulatory submissions (clinical trial and marketing applications) aligned to global filing plans and U.S. requirements.
- Implement product-related regulatory tactics in accordance with U.S. legislation/regulations and internal standards.
- Provide content guidance for key U.S. regulatory documents/meetings (e.g., briefing content, submission components).
- Support U.S. labeling development with the Labeling Working Group (LWG), including scientific data incorporation and labeling negotiation.
- Provide regulatory guidance on U.S. mechanisms/pathways (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use).
- Obtain/maintain clinical trial authorizations and marketing application approvals; support Responses to Questions (RTQs) and agency feedback.
- Communicate strategy/expectations with teams and assess success likelihood, expectations, and risks.
- Ensure ongoing regulatory compliance (e.g., IMR accuracy, PMCs/commitments, pediatric/agency obligations); proactively escalate issues.
- Maintain U.S. regulatory intelligence; monitor guidance/legislation and assess potential impact.
- Support Health Authority interactions; document outcomes and contribute to risk/contingency planning.
- Partner with cross-functional teams for alignment/execution, including U.S.-specific data use in communications (as applicable).
Basic Qualifications:
- Doctorate degree OR Master’s + 3 years OR Bachelor’s + 5 years OR Associate’s + 10 years OR High school/GED + 12 years, directly related.
- Experience directly managing people and/or leading teams/projects and directing resource allocation.
Preferred Qualifications:
- FDA regulatory submissions and agency interaction experience.
- Knowledge of U.S. legislation/regulations for medicinal products.
- Drug development and U.S. registration pathway knowledge (marketing applications, post-approval changes, extensions/renewals).
- Obesity/metabolic/endocrinology therapeutic area regulatory strategy experience.
- Scientific understanding of obesity/metabolic disease; knowledge of biological pathways and clinical endpoints.
- Labeling development and cross-functional collaboration (e.g., LWG).
- Strong written/oral communication.
- Risk anticipation and contingency planning.
- Conflict resolution; influence without authority; drive alignment.
- Ability to operate across global/regional teams.
Benefits:
- Comprehensive employee benefits package including Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; award-winning time-off; flexible work models where possible.
Application Instructions:
- Apply via careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or a candidate is selected. Sponsorship not guaranteed.