Regulatory CMC Manager Cell and Gene Therapy

Regulatory CMC Manager Cell and Gene Therapy

Job Responsibilities

The Chemistry Manufacturing Controls Manager will support the execution of cell and gene therapy global regulatory CMC strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support and guidance to various cross‑functional teams to ensure all applicable global regulatory requirements are considered and incorporated into development and commercial programs.

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Contributes to the development of global regulatory CMC strategies for commercial products.
• Works with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Provides regulatory CMC guidance to cross‑functional teams and key stakeholders.