Regulatory Manager / Senior Regulatory Manager
Source: remoteok
About the Role
Precision for Medicine is not your typical CRO. They have brought together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients. They integrate clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, with a strong focus on Oncology and Rare Disease.
Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join their team.
The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.
Essential Functions
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, ann