Company Summary:
My client, a full service CRO+ that is focused on providing support to global drug, vaccine, and medical device clients, is looking to add a Regulatory Manager to their team! This role will be hybrid based in Bethesda, Maryland.
The Regulatory Affairs Manager will be responsible for:
- Overseeing the Regulatory Team(s) and manage lifecycle of multiple drug and biologic INDs in accordance with FDA regulations
- Tracking, compiling, and reviewing of regulatory submissions including INDs, Annual Reports, Protocol Reports, etc.
- Managing regulatory team staff members and provide project management support
- Overseeing the tracking of regulatory activity, database maintenance, and ensuring records are complete and accurate
- Communicating effectively with clients, colleagues, and regulatory health/pharma staff
The Regulatory Affairs Manager should have the following qualifications:
- Ph.D. or M.S. or equivalent with 3+ years of experience in pharmacology, regulatory affairs, toxicology, immunology, or other applicable field
- Experience working with FDA and/or familiarity with GCP is preferred
- Experience preparing and submitting regulatory documents and submissions
