Regulatory Lead – Obesity and Related Conditions TA
Amgen
full-time
Posted on:
Location Type: Remote
Location: Illinois • Washington • United States
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Salary
💰 $153,935 - $184,298 per year
Job Level
About the role
- Execute the approved U.S. regulatory strategy for assigned programs and represent the region on global governance teams (e.g., GRT; may include GDT/CST/LWG as applicable)
- Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans, U.S. regulatory requirements, and Amgen standards
- Lead U.S. regulatory document development, including labels, briefing packages, and key submission components consistent with product strategy
- Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group (LWG), including negotiation approach, timelines, and deviation/waiver decisions as applicable
- Provide regulatory direction on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable)
- Lead Health Authority interactions for assigned products: build relationships, prepare/lead engagements, and document/communicate outcomes to GRT and senior management
- Manage Responses to Questions (RTQs) and other agency feedback by coordinating cross-functional inputs, driving alignment, and ensuring timely, high-quality responses
- Assess regulatory risk and likelihood of success; communicate scenarios, expectations, and contingencies to GRT and line management
- Ensure ongoing regulatory compliance for assigned products (e.g., commitments, obligations, regulatory history/record accuracy) and escalate issues proactively
- Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance and assess/communicate impact (including competitor labeling where relevant)
- Partner with cross-functional teams (Clinical, Medical, Safety, Commercial) to ensure strategy alignment, including support for U.S. promotional/data applicability considerations as needed
- If applicable, lead and develop staff through clear prioritization, coaching, and resource planning to meet program objectives
Requirements
- Doctorate degree and 2 years of directly related experience OR
- Master’s degree and 6 years of directly related experience OR
- Bachelor’s degree and 8 years of directly related experience OR
- Associate’s degree and 10 years of directly related experience
- Regulatory submissions experience and demonstrated experience interacting with regulatory agencies (FDA)
- Strong knowledge of the U.S. regulatory environment and drug development lifecycle
- Experience developing/implementing regulatory strategy, including risk management and contingency planning
- Experience leading U.S. labeling strategy, negotiation, and timeline management in a cross-functional setting
- Experience working with policies, procedures, and SOPs in a regulated environment
- Experience supporting programs in Obesity, Diabetes, or related metabolic diseases
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsU.S. regulatory strategylabeling strategyrisk managementcontingency planningclinical trial applicationsmarketing applicationsregulatory complianceregulatory intelligencedrug development lifecycle
Soft Skills
leadershipcommunicationrelationship buildingcross-functional collaborationcoachingprioritizationnegotiationalignmentproblem-solvingtimely response management