Associate Director, Regulatory CMC

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you?

About the Role

What You'll Do:

• Plan, execute and manage regulatory submissions for compounds in various phases of clinicaldevelopment, marketing applications, and post-approval lifecycle activities in Japan by working with globalregulatory affair CMC team.
• Provide regulatory strategies and identify the gaps and challenges of CMC development to ensure theapprovability of the drug products in Japan with the flexibility for post-approval maintenance and lifecyclemanagement of the marketed products.
• Develop plans for