Regulatory Affairs Director
5 days ago
Voyager Therapeutics, Inc. is seeking an experienced Associate Director to lead our Regulatory Affairs CMC team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing global Regulatory CMC strategies to secure approval of our gene therapy products.
Key Responsibilities:- Develop and execute global Regulatory CMC strategies to support the approval of our gene therapy products.
- Lead the preparation and submission of CMC sections of INDs, CTAs, BLAs, and MAAs.
- Collaborate with internal and external teams to ensure compliance with global regulatory requirements.
- Provide regulatory guidance and support to cross-functional teams.
- Develop and maintain relationships with regulatory authorities.
- Bachelor of Science degree and relevant experience, or MS, PhD degree preferred.
- Minimum 10 years experience working in Regulatory Affairs, ideally 7 plus years in the biotech industry.
- Sound depth of knowledge and expertise in Regulatory Affairs, including all associated requirements.
- Pharmaceutical industry experience in successfully transitioning from Phase 1 clinical trial material to Phase 3 and commercial GMP quality material.
- Deep experience interfacing with the FDA and other Health authorities.
- Extensive knowledge and understanding of global regulatory requirements for CMC and GMO environment.
- Demonstrated strategic thinking and problem-solving for CMC issues in the rapidly developing field of manufacturing gene therapy products.
- Must be detail-oriented, possess good analytical testing knowledge, including problem-solving skills.
- Must have excellent verbal and written communication skills, including strong interpersonal skills.
Voyager Therapeutics, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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