Regulatory CMC Manager, Cell and Gene Therapy

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

📋 Description

• Assist in the implementation of global regulatory CMC strategies for both marketed and developmental cell and gene therapy products.

• Aid in the preparation and submission of regulatory CMC documentation.

• Offer regulatory support and advice to various cross-functional teams, ensuring that all relevant global regulatory requirements are adequately addressed and integrated into development and commercial initiatives.

• Evaluate CMC sections of regulatory submissions, as well as interactions and responses with regulatory authorities.

• Contribute to the formulation of global regulatory CMC strategies for commercial products.

• Collaborate with regulatory colleagues in the development of global regulatory CMC strategies and submissions.

• Provide regulatory CMC guidance to cross-functional teams and key stakeholders.

• Assist in regulatory assessments and offer guidance on product compliance topics, including change controls, deviations, and GMP investigations.

⛳️ Requirements

• Excellent interpersonal skills for exchanging complex information and guiding others.

• Proficient in regulatory guidelines (FDA, EMA, Health Canada, and ICH).

• Experience in preparing and writing CMC submissions.

• Strong strategic thinking and problem-solving capabilities.

• Ability to collaborate and communicate in an open, clear, comprehensive, timely, and consistent manner.

• Strong planning and prioritization skills, with the ability to work with all management levels.

• Capable of strategic thinking and resolving complex and ambiguous situations.

• Sound knowledge of cGMP, FDA, EMA, and ICH standards.

• Bachelor’s degree, preferably in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another relevant life-science discipline.

🏝️ Benefits

• We are dedicated to the growth of our employees through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.