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- We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.
- The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology cell therapy products, from preclinical to eventual commercial stages.
- The ideal candidate should have relevant experience in CMC regulatory activities for investigation cell therapy products in oncology, and enjoy fast-paced, collaborative and vibrant startup culture.
- Develop and execute global CMC regulatory strategies for oncology cell therapy products in alignment with the company's objectives and regulatory requirements
- Provide CMC regulatory expertise and input to cross-functional teams, such as manufacturing, quality, research, and clinical development, to ensure alignment and compliance with CMC regulatory requirements
- Minimum of 10 years of experience in CMC regulatory affairs in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role
- Experience in developing and implementing global CMC regulatory strategies for cell therapy or gene therapy products is highly preferred
- Experience in preparing and submitting CMC sections of INDs, BLAs, and amendments for cell therapy or gene therapy products is required
Director, CMC Regulatory Affairs - Waltham, United States - Tscanrx
