Title: Senior Director, Global Regulatory CMC
Summary: A world renowned biotech company and a leader in the rare disease/vaccine space is expanding its team this year. Due to their rapid success, the team is looking for a Senior Director, Regulatory CMC to prepare and oversee the strategy for multiple products and support all regulatory activities. This professional will lead and manage a team of CMC experts while interacting with leadership and health authorities. The Senior Director should be an expert in the Regulatory CMC space, with a focus in biologics and global regulatory experience. This is a great opportunity for someone who is interested in rare disease and vaccines and looking to lead a team in an established, growing, and innovative company.
The Senior Director, Global Regulatory CMC will be responsible for:
- Provide regulatory CMC expertise for multiple development projects, facilitating review and approval of submissions.
- Develop and implement strategy for regulatory submissions with a team of Regulatory CMC experts
- Lead Regulatory CMC interactions with health authorities and review Regulatory CMC documents for submission.
- Provide expertise cross functionally as a leader on multiple programs for various therapeutic areas.
The Senior Director, Global Regulatory CMC should have the following qualifications:
- 10+ years biopharmaceutical experience, 8+ years in Regulatory CMC
- Strong knowledge of global health authority regulations
- MS/PhD in a relevant discipline
- Strong experience with biologics, CTD, and other regulatory submissions.
- Relocation package if needed
- Medical, dental, and vision coverage
- 401K match
- & so much more!
If you are interested in the Senior Director, Global Regulatory CMC role, then please don't wait to apply.