Lead Regulatory Affairs

Job description

The Marketing Company Regulatory Lead is responsible for leading regulatory affairs activities for assigned therapeutic franchises from clinical development through product lifecycle management. The role focuses on accelerating approvals of innovative medicines, additional indications, and clinical trials by developing and executing effective regulatory strategies and risk mitigation plans. The individual will ensure full compliance with internal and external regulatory requirements, including post-approval commitments, labeling updates, site transfers, biological products, and Good Regulatory Practices (GRP). The position requires extensive collaboration with business, medical, quality, supply chain, and international regulatory teams to align regulatory activities and support business objectives. Key responsibilities include regulatory intelligence, health authority engagement, policy advocacy through industry associations, audit and inspection readiness, management of corrective and preventive actions (CAPAs), regulatory support for business development initiatives, and oversight of team training and development.