Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences. We are recruiting a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials.

Requirements

• Provides regulatory guidance throughout the clinical development life cycle
• Compiles, coordinates, and reviews applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities
• Serves as a representative of Global Regulatory Affairs at project team meetings
• Maintains project plans, trackers, and regulatory intelligence tools
• Assists in developing Regulatory Affairs Specialists and other operational area staff
• Provides ICH GCP guidance, advice, and training to internal and external clients
• Serves as a representative of Global Regulatory Affairs at business development meetings

Benefits

• Company offers unspecified benefits