United States Regulatory Manager – Obesity and Related Conditions

United States Regulatory Manager – Obesity and Related Conditions

Key Responsibilities
- Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams (e.g., GRT; may include GDT/CST/LWG as applicable).
- Plan and manage U.S. regulatory submissions (clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements.
- Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards.
- Provide content guidance for key U.S. regulatory documents and meetings consistent with GRT strategy (e.g., briefing content, submission components).
- Support U.S. labeling development with the Labeling Working Group (LWG), incorporating scientific data/guidance/precedent; support labeling negotiation activities.
- Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use).
- Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback.
- Communicate regulatory strategy and expectations within the team and work with line management to assess success likelihood, expectations, and risks.
- Ensure ongoing regulatory compliance (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); proactively escalate issues.
- Maintain and apply U.S. regulatory intelligence by monitoring legislation/guidance and researching precedent/history to assess and communicate impact.
- Support Health Authority interactions as appropriate, document outcomes, and contribute to risk/contingency planning.
- Partner with cross-functional teams to align and execute, including U.S.-specific considerations for data use in product communications.

Basic Qualifications
- Doctorate degree
OR Master’s degree and 2 years of directly related experience
OR Bachelor’s degree and 4 years of directly related experience
OR Associate’s degree and 8 years of directly related experience
OR High school diploma/GED and 10 years of directly related experience

Preferred Qualifications (skills/experience)
- Regulatory submissions experience and experience interacting with FDA.
- Working knowledge of U.S. legislation/regulations for medicinal products.
- Understanding of drug development and U.S. registration pathway (marketing applications, post-approval changes, extensions/renewals).
- Experience supporting regulatory strategy for obesity/metabolic disorders/endocrinology (foundational scientific understanding and familiarity with key pathways and clinical endpoints such as weight loss, cardiovascular outcomes, metabolic biomarkers).
- Experience supporting labeling development and cross-functional collaboration (e.g., LWG participation).
- Strong written and oral communication skills.
- Ability to anticipate issues, evaluate risks, and contribute to contingency planning.
- Ability to resolve conflicts, influence without authority, and drive alignment across teams.
- Cultural awareness and ability to operate effectively across global/regional teams.

Benefits
- Comprehensive employee benefits package (Retirement and Savings Plan, group medical/dental/vision, life/disability insurance, flexible spending accounts)
- Discretionary annual bonus (or sales-based incentive for field sales)
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible

Application Instructions
- Apply now via careers.amgen.com.