- Own regulatory strategy across active programs, integrating CMC and clinical plans with development milestones and commercial objectives.
- Provide regulatory input to portfolio planning, program prioritization, and business development.
- Develop regulatory intelligence capabilities and communicate regulatory updates and risk assessments to executive leadership and the board.
- Lead CMC regulatory activities, including filing strategy, CMC section authorship and review, change management, and oversight of manufacturing and CDMO partners.
- Lead clinical regulatory activities, including IND strategy and management, protocol review, study report oversight, and integration of clinical data into submissions.
- Own approval submission strategy and execution, coordinating submission-ready packages across CMC, Clinical, and Quality.
- Serve as the primary liaison with regulatory agencies, leading pre-submission meetings, formal submissions, and ongoing communications.
- Manage post-approval obligations, including periodic reports, labeling updates, study commitments, and CMC variation filings.
- Establish regulatory information management, eCTD publishing, submission archiving, and procedural standards.
- Build and lead the regulatory organization and establish governance across CMC regulatory, clinical regulatory, submissions, labeling, and regulatory operations.