Find & Apply For Regulatory Affairs Manager Jobs in Wheeling, Illinois

Lundbeck seeks a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. You will drive product lifecycle planning, oversee submissions (INDs, NDAs, sNDAs), and interface with FDA and ex-U.S. health authorities. Partner with R D, Clinical, Commercial, and Legal & Regulatory Compliance to ensure robust regulatory frameworks, risk assessments, and labeling strategies that align with patient and business needs. You will mentor junior staff and champion Lundbeck's purpose-driven, patient-focused culture grounded in integrity, inclusion, and collaboration. Responsibilities Lead U. S. and global regulatory strategy for assigned neuroscience products across the lifecycle Own planning, preparation, and submission of INDs, NDAs, supplements, and other regulatory filings Serve as primary regulatory liaison with FDA and other health authorities, leading meetings and correspondence Partner with Legal & Regulatory Compliance to ensure adherence to relevant laws, regulations, and guidance Provide regulatory input into clinical development plans, study designs, and labeling strategies Assess regulatory risks and develop mitigation plans that balance patient, compliance, and business needs Review and advise on labeling, promotional, and medical materials for regulatory compliance Represent Regulatory on cross-functional teams with R D, Clinical, Commercial, and Quality Mentor and develop junior regulatory staff, promoting a culture of integrity and inclusion Monitor evolving regulatory requirements and translate changes into actionable guidance for the business Required Skills Regulatory strategy development FDA and ex-U. S. regulatory pathways (IND, NDA, s

NDA, MAA

) CTD/e CTD submission management Labeling and promotional review Regulatory risk assessment and mitigation Cross-functional leadership and collaboration Regulatory writing (briefing books, meeting requests, responses) Clinical development and lifecycle management knowledge Neurology/psychiatry therapeutic area knowledge Project and stakeholder management