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About the role
Key responsibilities & impact- Support products in the Obesity and Related Conditions Therapeutic Area
- Develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL)
- Represent the U.S. on global teams and contribute to global regulatory and clinical development strategies
- Plan and lead U.S. regulatory submissions in alignment with global filing plans and regulatory requirements
- Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy
- Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group
- Lead Health Authority interactions for assigned products
- Assess regulatory risk and likelihood of success; communicate scenarios and contingencies to the GRL, GRT, and senior management.
- Ensure ongoing compliance for assigned products and proactively escalate issues
Requirements
What you’ll need- 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 OR High school diploma / GED and 12 years of directly related experience
- Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
- Experience supporting or leading regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or related therapeutic areas.
- Strong scientific literacy in obesity and metabolic disease, including metabolic pathways, weight regulation biology, and relevant clinical endpoints (e.g., weight loss, cardiovascular outcomes, metabolic biomarkers).
- Experience leading U.S. labeling strategy, including negotiation and timeline management in a cross-functional environment.
- Experience working with policies, procedures, and SOPs in a regulated environment.
Benefits
Comp & perks- 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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory Document DevelopmentRegulatory ComplianceRisk AssessmentClinical Development StrategyNegotiation Skills
Soft Skills
Team LeadershipCommunication SkillsCross-Functional Collaboration