Senior Manager Regulatory Strategy

Overview Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. In this Legal & Regulatory Compliance role, you will shape development and registration plans, drive submissions (INDs, NDAs, sNDAs), and provide strategic guidance to cross‑functional teams. You will interface with FDA and other health authorities, assess regulatory risks, and ensure compliance with evolving requirements. At Lundbeck, you’ll work in a collaborative, patient‑focused culture with strong support for learning, development, and career growth in a mission‑driven environment. Responsibilities Lead U.S. and global regulatory strategy for assigned neuroscience products across development and commercialization lifecycle Own planning, preparation, and submission of INDs, NDAs, sNDAs and other regulatory filings Serve as primary regulatory point of contact to cross‑functional teams (R&D, clinical, safety, commercial, legal) Plan and lead interactions and meetings with FDA and other health authorities Monitor and interpret evolving regulatory requirements and guidances and translate into internal strategies Identify, communicate, and mitigate regulatory risks for pipeline and marketed products Ensure regulatory and promotional compliance in partnership with Legal & Regulatory Compliance Contribute to labeling strategy, negotiation, and lifecycle management Mentor junior regulatory staff and support best‑practice processes and tools Support due diligence and business development activities from a regulatory perspective Develop regulatory strategy for assigned neuroscience products Qualifications Knowledge of FDA regulations and guidance Global regulatory affairs (ICH, EMA) knowledge Regulatory submissions (IND, NDA, sNDA, CTA) Labeling and promotion regulatory review Risk assessment and mitigation Cross‑functional leadership and collaboration Project and portfolio management Scientific and clinical data interpretation Health authority meeting preparation and negotiation RAC (Regulatory Affairs Certification) preferred JD or other advanced degree in law/compliance a plus Certification in Healthcare Compliance (CHC) a plus Project management certification (e.g., PMP) a plus Benefits Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k #J-18808-Ljbffr Chapter 13 Trustee Middle District of Alabama