Senior Director, Regulatory CMC

- Global Regulatory CMC Strategy:
Develop and execute integrated regulatory strategies for small-molecule programs, supporting development from preclinical stages through late-stage clinical development, marketing applications, and lifecycle management.

- Late-Stage Development and Registration:
Lead regulatory CMC activities for advanced development programs, including NDA-enabling work, marketing application preparation, and strategies to support successful product registration.

- Technical and Scientific Leadership:
Provide strategic guidance across drug substance, drug product, analytical development, manufacturing processes, specifications, and control strategies to ensure robust development and regulatory readiness.

- Cross-Functional Collaboration:

Serve as the Regulatory CMC subject matter expert on program teams, aligning CMC development plans with clinical, regulatory, quality, manufacturing, and business objectives.

- Regulatory Submission Management:
Lead the preparation, review, and approval of CMC documentation for global regulatory submissions, including INDs, CTAs, IMPDs, NDAs, supplements, variations, briefing packages, and responses to health authority questions.

- Health Authority Engagement:
Provide expert input into regulatory interactions, interpret agency feedback, and develop scientifically sound responses that support development milestones and registration objectives.

- Regulatory Intelligence:
Monitor evolving global regulatory requirements, FDA and EMA guidance, ICH standards, and relevant regulatory precedents, incorporating new insights into development and submission strategies.

- External Partner Management:
Oversee contract development and manufacturing organizations (CDMOs) and other external partners, including partner selection, performance management, technology transfer, process scale-up, validation, and manufacturing readiness.

- Quality and Compliance:
Ensure that development and manufacturing activities align with applicable global regulatory requirements, current Good Manufacturing Practices (cGMP), and relevant quality standards.

- Inspection and Supply Readiness:
Support regulatory inspection readiness and clinical supply continuity by identifying potential risks, strengthening documentation, and coordinating mitigation activities with internal and external stakeholders.

- Project and Resource Management:
Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies to ensure efficient execution of regulatory CMC activities.

- Risk Assessment and Decision Support:
Evaluate regulatory and technical risks, communicate potential impacts, and recommend practical solutions that balance scientific rigor, development timelines, and business objectives.

- Stakeholder and Partner Relationships:
Build effective working relationships across internal functions, external development organizations, manufacturing partners, and regulatory stakeholders to advance program goals.

- Education:

A master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline is required. A PhD or PharmD is preferred.

- Industry

Experience:

At least 12 years of pharmaceutical industry experience, including a minimum of five years in Regulatory CMC roles supporting small-molecule development programs.

- Late-Stage Regulatory Leadership:
Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions, is required.

- Regulatory Submission Expertise:
Demonstrated experience authoring, reviewing, and managing CMC content for regulatory filings, including INDs, IMPDs, NDAs, and other global submissions.

- Health…