Amgen

Regulatory Manager – Obesity, Related Conditions

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $112,744 - $152,536 per year

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsU.S. legislationregulatory principlesdrug developmentmarketing applicationslabeling developmentclinical trial authorizationsFDA interactionsobesitymetabolic disorders
Soft Skills
written communicationoral communicationrisk evaluationconflict resolutioninfluence without authorityteam alignmentcultural awarenessanticipating issuescontingency planningcross-functional collaboration
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED