7 months ago
Our client is an exciting biotech company operating in the oncology space seeks a CMC Regulatory Affairs professional at director level to ultimately lead the CMC strategy and filings for the company. The client is publically traded and looking for the qualified individual to be based in their MA office.
- You are responsible for the implementation of the global regulatory affairs CMC strategies of the company's treatment pipeline and marketed products
- You will lead the regulatory CMC function, responsible for strategically hiring and developing the team to maximize its potential
- Your role will involve strategic CMC exercises including submissions (INDs, NDAs CTAs, IMPDs, MAAs) and regulatory body interactions
- You will report to the Vice President Regulatory Affairs and serve as CMC product lead
- Collaborate with internal and external CMC staff, contractor consultants, CROs etc.
- Keep abreast of regulatory changes in relation to RA CMC and apply any industry changes to the everyday procedures and policies
- Minimum of M.S. degree in pharmacy, biochemistry chemistry or similar
- Previous experience with submissions including INDs, NDAs CTAs, IMPDs, and MAAs
- Knowledge of FDA and ICH CMC regulations and guidelines, EU and other regional CMC regulations required
- Strong team player and problem solver
Apply here or email email@example.com if you are interested in working with a leader in the biopharma space.