Head of Global Regulatory CMC

Location : Warren, NJ

Hybrid Position

My client is a global clinical-stage biopharmaceutical organization focused on developing innovative therapies for immunologic diseases with significant unmet medical needs. They are seeking a Head of Global Regulatory CMC to join their growing team.

Position : In this role, you will provide strategic leadership for the global regulatory efforts, guiding the development and execution of CMC strategies for complex biologic and drug-device combination products. The Head of Global Regulatory CMC will be responsible for authoring and driving submissions of critical regulatory documents, including IMPDs, INDs, BLAs, NDAs, CTAs, FDA briefing packages, and MAAs, ensuring the highest quality and compliance standards.

This is an exceptional growth opportunity to join a mission-driven team pioneering next-generation therapies for patients worldwide and to play a vital role in bringing transformative treatments to market.

KEY RESPONSIBILITIES :

• Point of contact for regulatory CMC expertise at health authority meetings and interactions.
• Prepare Module 3s of BLAs and MAAs for drug / device (patch) combination products for food allergies and prepare the CMC sections of INDs and IMPDs for early-stage products.
• Develop and coordinate CMC submissions to regulatory authorities, monitor progress, and coordinate written and verbal (during meeting) responses.
• Provide leadership, support, and expertise in preparing and finalizing all necessary manufacturing documents in support of IND, BLA, NDA, MAA, and other critical applications.
• Review CMC-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development.
• Closely Partner with internal stakeholders and external CDMOs / testing facilities to maintain inspection readiness and operational excellence.
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities.

QUALIFICATIONS :