Regulatory Manager Senior Regulatory Manager

About the Role

Precision for Medicine is not your typical CRO. We have integrated clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed and success rate of bringing life-changing therapies to patients, with a strong focus on Oncology and Rare Disease.

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. Key responsibilities include:

• Providing regulatory guidance throughout the clinical development life cycle.
• Compiling, coordinating, and reviewing applications to Regulatory Authorities including, but not limited to, CTA and IND.
• Ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable regulations.
• Coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees.

Required Skills