Title: Director, Regulatory CMC
Summary: A clinical-stage biopharmaceutical company is actively seeking an experienced Regulatory CMC professional to join the groundbreaking work being developed in their Greater Boston location. The ideal candidate will have late phase & biologics experience and will act as the team lead for supporting all Regulatory CMC strategies across the pipeline. Are you a motivated Regulatory CMC professional eager to lead a product to the market? If so, please apply!
The Director, Regulatory CMC will be responsible for…
- Contributing to the development and implementation of Regulatory strategy for products in Pipeline
- Facilitating interactions with internal teams and external partners, including managing CMC Regulatory risks/gaps to execute team objectives
- Supporting regulatory strategies necessary to evaluate CMC options, enable plans, and optimize development programs
- Authoring/reviewing responses to regulatory questions and manage regulatory feedback in updates to submissions and CMC-related
- Staying up to speed on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions
The Director, Regulatory CMC should have the following qualifications…
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
- 8+ years of regulatory Affairs CMC experience
- Extensive direct experience with biologic (BLA) processes and life cycle development, especially in late-stage development
- proven ability to represent Regulatory CMC on project teams and to Health Authorities
