Manager, Regulatory Affairs
A specialty pharmaceutical company is currently seeking a Manager Regulatory Affairs to join their team to assist in supporting and developing regulatory strategies. This position is an onsite Contract to Hire role in Palo Alto, CA and reports to the Senior Director Regulatory Affairs
Responsibilities:
- Support and develop global regulatory strategies -including CMC, non clinical and clinical
- Assist in the development of global regulatory and clinical plans
- Implement strategies
- Prepare and manage submissions
- Provide prompt preparation of organized and scientifically valid submissions
- Assist in translating regulatory requirements into workable plans
Requirements:
- BS or MS in a scientific discipline
- 3+ years regulatory affairs experience in the biopharmaceutical industry
- Experience leading teams in preparing investigation and marketed product submissions
- International regulatory affairs experience (preferred)
- Experience with regulatory requirements including ICH and regional requirements
- Experience filing regulatory dossiers : CTA's IND's, IMPD's (required)
- Experience with BLAs/NDAs/MAAs (is a plus)
If interested in the Manager Regulatory Affairs position don't hesitate, apply now!
