Manager – United States Regulatory Strategy, General Medicine

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

📋 Description

• Implement U.S. regulatory strategies and deliverables for designated programs while representing the region on global teams.

• Organize and oversee U.S. regulatory submissions (such as clinical trial and marketing applications) in alignment with global filing strategies and U.S. regulatory standards.

• Execute product-related regulatory strategies and action plans in compliance with U.S. laws, regulations, and internal protocols.

• Offer content guidance for important U.S. regulatory documents and meetings in line with Global Regulatory strategy (including briefing materials and submission elements).

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

• Provide regulatory advice on U.S. mechanisms and pathways to enhance development (such as expedited programs, orphan drug considerations, pediatric plans, and compassionate use where necessary).

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

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

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

• Maintain and utilize U.S. regulatory intelligence: keep abreast of evolving legislation/guidance; research precedents and historical contexts; assess and communicate potential impacts (including competitor labeling when relevant).

• Facilitate Health Authority interactions by acting as a liaison with agencies as appropriate, documenting outcomes, and contributing to risk/contingency planning in accordance with global strategy.

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

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of directly relevant experience OR Bachelor’s degree with 4 years of directly relevant experience OR Associate’s degree with 8 years of directly relevant experience OR High school diploma / GED with 10 years of directly relevant experience.

• Experience with regulatory submissions and interacting with regulatory agencies (FDA).

• Proficient understanding of U.S. legislation/regulations concerning medicinal products and applicable regulatory principles.

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

• Experience in supporting regulatory strategies for programs in general medicine, metabolic disorders, endocrinology, or related therapeutic areas.

• Foundational scientific knowledge of cardiovascular and metabolic diseases.

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

• Capacity to anticipate issues, assess risks, and contribute to practical contingency planning.

• Ability to resolve conflicts, influence without direct authority, and foster alignment across teams.

• Cultural awareness and the capability to operate effectively within 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.