Regulatory Manager – Obesity, Related Conditions
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Job Description
Regulatory Manager at Amgen overseeing U.S. regulatory strategy and compliance for Obesity products. Leading clinical trial support and regulatory submissions for product licensing.
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 (e.g., 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 in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. 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 where applicable).
- 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 (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks.
- Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively.
- Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant).
- Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy.
- Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable).
Requirements:
- 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
- Regulatory submissions experience and experience interacting with regulatory agencies (FDA)
- Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles
- Understanding of drug development and the U.S. registration pathway (e.g., marketing applications, post-approval changes, extensions/renewals)
- Experience supporting regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or related therapeutic areas.
- Foundational scientific understanding of obesity and metabolic disease, including familiarity with key biological pathways and relevant clinical endpoints (e.g., 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 communicate scientific/clinical information clearly
- Ability to anticipate issues, evaluate risks, and contribute to practical 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:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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