Senior Manager, U.S. Regulatory Strategy – Obesity and Related Conditions

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support for products within the Obesity and Related Conditions Therapeutic Area.

• Collaborate closely with the Global Regulatory Lead (GRL) to formulate and implement regulatory strategies.

• Represent the U.S. on international teams and contribute to global regulatory and clinical development initiatives.

• Organize and oversee U.S. regulatory submissions in accordance with global filing strategies and regulatory standards.

• Spearhead the creation of essential regulatory documents, such as labels, briefing packages, and submission components that align with product strategies.

• Drive the U.S. labeling strategy and its execution in partnership with the Labeling Working Group.

• Lead interactions with Health Authorities for the products assigned.

• Evaluate regulatory risks and the potential for success; relay scenarios and contingencies to the GRL, GRT, and senior management.

• Maintain compliance for assigned products and proactively address any emerging issues.

⛳️ Requirements

• Doctorate degree with 2 years of relevant experience, or a Master's degree with 6 years of relevant experience, or a Bachelor's degree with 8 years of relevant experience, or an Associate's degree with 10 years of relevant experience, or a High school diploma / GED with 12 years of relevant experience.

• At least 2 years of experience in directly managing personnel and/or leadership experience in guiding teams, projects, programs, or managing resource allocation.

• Experience in supporting or leading regulatory strategies for programs in obesity, metabolic disorders, endocrinology, or similar therapeutic fields.

• Strong scientific understanding of obesity and metabolic diseases, encompassing metabolic pathways, weight regulation biology, and pertinent clinical endpoints (e.g., weight loss, cardiovascular results, metabolic biomarkers).

• Proven experience in leading U.S. labeling strategy, including negotiation and timeline management within a cross-functional setting.

• Familiarity with policies, procedures, and Standard Operating Procedures (SOPs) in a regulated environment.

🏝️ 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 a sales-based incentive plan for field sales representatives.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where applicable.