FierceBiotech and FiercePharma Jobs
Manager Regulatory Affairs - MR-Raleigh
Sep 11
Location: Raleigh, NCCategories: All Categories
Position Description
My client is Public Pharmaceutical company focused on developing innovative pharmaceuticals for oncology drugs which are tumor-targeting treatments using Proprietary drug delivery systems.
Manager Regulatory Affairs
Description:
This will be a senior level position that will have responsibility for:
1. Advising the Executive Director, QA and RA and the Chief Medical Officer on strategic pathways for product registrations in both the US and EU.
2. Executes agreed strategy supporting worldwide regulatory IND filings.
3. Planning and implementing a process for eventual eCTD filing utilizing either internal or external contract resources.
4. Develops and implements a centralized database to contain company wide information needed for NDA
5. Guides the manager of RA in the development of a filing system for FDA and/or EU communications.
6. Assists Clinical Operations with the development of protocols and other submissions necessary for initiation of clinical trials around the world.
7. Represents Regulatory Affairs in project team meetings.
Job Qualifications:
Bachelor’s degree in a scientific discipline
Minimum of five (5) years experience in a regulatory position within a biotech, pharmaceutical or clinical research organization
Experience with electronic filing submissions preferred
Michael A. Terretti
Managing Director
Global Life Sciences
MRI-Raleigh
919-781-0400×112 office
mterretti@mriraleigh.com
