Manager, Regulatory Strategy – Obesity and Related Conditions

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

📋 Description

• Implement the regulatory strategy and deliverables for U.S. programs while representing the region on global teams (e.g., GRT; may also involve GDT/CST/LWG as applicable).

• Organize and oversee U.S. regulatory submissions (e.g., clinical trial and marketing applications) in line with global filing strategies and U.S. regulatory standards.

• Execute product-related regulatory tactics and activity plans in compliance with U.S. laws, regulations, and internal guidelines.

• Offer content guidance for critical U.S. regulatory documents and meetings in alignment with GRT strategy (e.g., briefing materials, submission components).

• Assist in the development of U.S. labeling in partnership with the Labeling Working Group (LWG), integrating scientific data, guidance, and precedents; facilitate U.S. labeling negotiation processes.

• Provide regulatory insights on U.S. mechanisms and pathways to enhance development (e.g., expedited programs, orphan considerations, pediatric strategies, compassionate use where applicable).

• Secure and uphold clinical trial authorizations and marketing application approvals, including assistance with Responses to Questions (RTQs) and other agency inquiries.

• Convey regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and collaborate with line management to evaluate success probabilities, expectations, and risks.

• Ensure continuous regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency responsibilities); proactively escalate issues.

• Maintain and utilize U.S. regulatory intelligence: track evolving legislation/guidance; investigate precedents and history; assess and communicate potential impacts (including competitor labeling where relevant).

• Facilitate interactions with Health Authorities by serving as an agency contact as necessary, documenting outcomes, and contributing to risk/contingency planning in line with global strategy.

• Collaborate with cross-functional teams to ensure alignment and execution, including U.S.-specific considerations for data utilization in product communications (when applicable).

⛳️ Requirements

• Doctorate degree OR Master’s degree with 3 years of relevant experience OR Bachelor’s degree with 5 years of relevant experience OR Associate’s degree with 10 years of relevant experience OR High school diploma / GED with 12 years of relevant experience.

• Experience in directly managing personnel and/or leadership experience in guiding teams, projects, programs, or directing resource allocation.

• Experience with regulatory submissions.

• Background in interacting with regulatory agencies (FDA).

• Proficient understanding of U.S. legislation/regulations pertaining to medicinal products and relevant regulatory principles.

• Knowledge of drug development and the U.S. registration process (e.g., marketing applications, post-approval changes, extensions/renewals).

• Experience in supporting regulatory strategy for programs related to obesity, metabolic disorders, endocrinology, or similar therapeutic areas.

• Foundational scientific knowledge of obesity and metabolic diseases, including a grasp of key biological pathways and relevant clinical endpoints (e.g., weight loss, cardiovascular outcomes, metabolic biomarkers).

• Experience in supporting labeling development and fostering cross-functional collaboration (e.g., participation in LWG).

• Excellent written and verbal communication skills; ability to convey scientific/clinical information clearly.

• Ability to foresee issues, assess risks, and contribute to effective contingency planning.

• Capacity to resolve conflicts, influence without authority, and promote alignment across teams.

🏝️ Benefits

• A comprehensive employee benefits package, featuring 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.