Title: Associate Director/Director Regulatory CMC
Summary: An innovative biotech company pioneering the gene therapy space is looking to bring on an expert in Regulatory CMC this year. With a broad and deep pipeline of over 10 programs, the team is utilizing their groundbreaking platform to address multiple cancers and high-risk diseases. In light of their success, they are looking to bring on a Regulatory Affairs CMC professional who demonstrates Regulatory expertise, creative thinking and hands on experience with drug discovery.
The Associate Director/Director Regulatory CMC will be responsible for:
- Developing, implementing, and prioritizing regulatory CMC strategy for the end to end lifecycle of small molecule products
- Collaborate with cross functional teams to provide regulatory CMC expertise and guidance on multiple programs
- Managing relevant regulatory submissions (IND, CTA, NDA, MAA) and anticipating/assessing health authority questions and concerns.
- Act as the main point of contact and Regulatory CMC representative for health authorities, preparing for and conducting meetings and discussions.
The Associate Director/Director Regulatory CMC should have the following qualifications:
- Bachelor's degree in science required, advanced degree preferred.
- 8+ years of experience in Regulatory Affairs in the biopharma industry from early to late-stage drug development
- Strong working knowledge of current regulations, global regulatory submission preparation, and cGMP
- Ability to lead multiple projects, demonstrated cross-functional leadership skills, and a collaborative, team-oriented approach.
If you are interested in the Associate Director/Director Regulatory CMC role, then please don't wait to apply.
