Our client is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for orphan and common neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Founded by renowned scientists, this company develops new therapeutics using proprietary technology and techniques.
We are currently looking for an Associate Director/Director Regulatory Affairs to join the team. This is a dynamic role for a growing company. It reports to the Chief Regulatory Officer located in Europe and will lead the Regulatory Affairs function in the United States.
- Acts as the Company’s point of contact for the FDA
- Strong background in chemistry/biologics and experience with Module 3 components of INDs/IMPDs and NDAs/MAAs
- Work with the Head of CMC to develop a regulatory strategy
- Participate in submissions to the FDA, including IND and NDA applications
- Bachelor’s Degree required, advanced degree (especially Pharma) preferred
- 5+ years pharmaceutical regulatory affairs experience with a focus on CMC
- Sound working knowledge of regulatory requirements (e.g. FDA/ICH, GCP, GMP Regulations), experience with submissions (IND, NDA/BLA), and regulatory responses
- Regulatory Affairs Society (RAPS) certification preferred
This is a fast-paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required.
Ongoing search to fill this position is occurring during the COVID-19 New Jersey Statewide Stay at Home Order and as such, job functions may start out as a work from home position with the intent being that they will transition back to in-office along the same timeline as the rest of the in-office personnel.