What are the responsibilities and job description for the Director of Global Regulatory Compliance position at beBee Careers?
Job Description
We are looking for a highly skilled and experienced CMC Regulatory Strategist to join our team. This role requires a strong understanding of global regulatory guidelines and requirements.
Main Responsibilities
- Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.
- Provide strategic guidance on CMC aspects of regulatory submissions, including INDs, BLAs, and ex-US submissions.
- Author and review CMC-related regulatory documents for submissions, including Module 2.3, Module 3, IMPD, and other CMC-associated documents.
Requirements
- Bachelor's degree in a scientific field, preferably with advanced degree and regulatory affairs certification.
- A minimum of 6-10 years in the biotechnology industry, with 4-5 years in Regulatory Affairs CMC.
- Background in biologics development is highly desirable.
