Associate Director, CMC Regulatory Affairs

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

📋 Description

• Oversee the global regulatory strategy and execution for gene therapy initiatives.

• Formulate and execute comprehensive global CMC regulatory strategies for gene therapy projects.

• Draft and evaluate CMC components of international regulatory submissions.

• Assist in agency meetings and act as a subject matter expert.

⛳️ Requirements

• PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or a related discipline.

• Hands-on experience with AAV, lentiviral, or other gene therapy technologies.

• 7–10 years of experience in regulatory affairs and CMC for the Associate Director role.

• 10–15+ years of experience in regulatory affairs for the Director role.

• Knowledge of global regulatory standards for advanced therapy medicinal products (ATMPs).

• Exceptional regulatory writing and communication abilities.

🏝️ Benefits

• Health insurance

• Flexible work arrangements

• Professional development