Regulatory CMC Manager – Cell & Gene Therapy

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the implementation of regulatory CMC strategies for cell and gene therapies related to marketed products.

• Plan and execute international regulatory CMC submissions, which includes developing content plans and ensuring alignment across functions.

• Review CMC sections of regulatory submissions and manage interactions and responses with regulatory authorities.

• Play a vital role in formulating global regulatory CMC strategies for commercial products.

• Collaborate with regulatory and technical teams to ensure the timely submission and approval of CMC modifications in a post-approval setting.

• Offer regulatory CMC expertise to cross-functional teams and key stakeholders.

• Assist in the regulatory evaluation and guidance related to product compliance issues, such as change controls, deviations, and GMP investigations.

⛳️ Requirements

• A Bachelor’s degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or a related life sciences discipline.

• A minimum of 5 years of experience in Regulatory CMC, including specific experience in Cell and Gene Therapy Regulatory CMC.

• Familiarity with FDA, EMA, and international regulatory guidelines.

• Excellent interpersonal skills to communicate complex information effectively and guide others.

• Experience in preparing, reviewing, and submitting CMC post-approval variations.

• Strong organizational abilities, strategic thinking, and problem-solving skills.

• Capacity to collaborate and communicate in a clear, timely, and consistent manner.

• Proficient in strategic thinking with the ability to navigate complex and ambiguous situations.

🏝️ Benefits

• Overtime compensation in compliance with federal and state regulations.