Manager Regulatory Affairs
My client is a growing bio-pharmaceutical company that is currently advancing a portfolio of injectable drug candidates to provide significant relief for pain management. The Vice President of Regulatory would describe the company culture as being a talented, devoted thoughtful and team oriented. They are seeking a Manager of Regulatory Affairs who will thrive in such an atmosphere. In this brand new role, you will be planning and coordinating regulatory submissions and providing guidance to cross-functional teams on regulatory strategy and tactic. The ideal candidate must be easy to work with, flexible, outgoing, and have strong communication skills.
Responsibilities:
- Ensure regulatory submissions are maintained in compliance with regulatory requirements
- Plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical and CMC
- Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
- Manage, evaluate and complete regulatory projects consistent with company goals
Knowledge and Skills:
- Minimum BS required, advanced degree preferred
- Minimum 5 years’ experience in regulatory affairs within the biopharmaceutical industry
- Working knowledge of GMP, GLP and GCP regulations as well an understanding of the pharmaceutical product life cycle
- Working knowledge of regulations related to development and commercialization of biopharmaceuticals
- Experience and knowledge in preparation of INDs and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD