Regulatory Product Manager

Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. Reporting into Legal & Regulatory Compliance, you will guide products from development through post‑marketing, shape regulatory positions, and ensure compliance with FDA and ex‑US requirements. You will collaborate cross‑functionally with R&D, clinical, CMC, and commercial teams, lead interactions and submissions with health authorities, assess regulatory risk, and influence labeling and lifecycle strategies. In Lundbeck’s patient‑focused, inclusive culture, you’ll mentor junior staff while driving high‑impact regulatory outcomes that advance brain health worldwide. Responsibilities Develop and lead U.S. and global regulatory strategies for neuroscience products across the lifecycle Plan, author, and oversee high‑quality regulatory submissions (e.g., INDs, NDAs, BLAs, amendments, supplements) Lead regulatory interactions with FDA and other health authorities, including meeting preparation and briefing documents Partner with R&D, clinical, CMC, safety, and commercial teams to align regulatory plans with program and business objectives Interpret and communicate evolving regulatory requirements, guidance, and risks to senior stakeholders Drive labeling strategy and negotiation to support differentiated product positioning and patient safety Ensure compliance with applicable regulations, policies, and quality standards across assigned projects Contribute to portfolio and scenario planning, providing regulatory input into asset and indication prioritization Mentor and coach junior regulatory staff, fostering a collaborative, high‑performance culture Represent Regulatory Affairs within Legal & Regulatory Compliance and cross‑functional governance forums Qualifications Regulatory strategy development FDA and ex‑US regulatory requirements NDA/BLA/MAA submission management CTD/eCTD preparation and reviewLabeling strategy and negotiation Clinical development and trial design understanding CMC regulatory knowledge Risk assessment and mitigation Cross‑functional leadership and collaboration Regulatory agency meeting planning and execution RAC (Regulatory Affairs Certification) preferred Admitted to practice law in at least one U.S. jurisdiction (if JD background) Project management training (e.g., PMP) a plus Benefits Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k #J-18808-Ljbffr