United States Regulatory Manager – Obesity and Related Conditions

• 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)

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

• 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, and 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