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Associate Director, Regulatory Affairs
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- The primary duty of the Associate Director, Regulatory Affairs is to support regulatory strategy for product development and manufacturing activities for the Cell & Gene Therapy sites to ensure compliance with GMP regulations and to support preparation and filing of regulatory submissions for clients.
- The Associate Director, Regulatory Affairs will be interpreting and evaluating reports and other documents to be used in all typical regulatory submissions, reviewing new and revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance.
- Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure compliance with GMP regulations, assisting in training of regulatory department and cross-functional areas in regulatory requirements.
- The Associate Director, Regulatory Affairs will review change control for potential impact on client or company submissions, providing regulatory guidance and support for development and production activities, interacting with clients, and maintaining awareness of changes in regulatory requirements for effective regulatory submissions
- Bachelor’s degree in Chemistry, Biology, Engineering or equivalent, required
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