Project Manager, Regulatory Affairs

Job Summary

A company is looking for a Project Manager, Regulatory Affairs.

Key Responsibilities

• Manage and lead the planning, preparation, and execution of high-quality regulatory projects
• Interface with internal departments, leadership, sponsors, and vendors
• Integrate consulting activities across various areas including CMC, quality, regulatory, clinical, and business

Required Qualifications

• Bachelor's degree in life/health sciences or related discipline, or equivalent required
• 4 to 6 years of relevant regulatory experience in a Clinical Research Organization or Pharmaceutical Company, with at least 2 years in Project Management or as a functional team lead
• Good working knowledge of the drug development process and regulatory requirements, including ICH guidelines
• Action-oriented and resilient in a fast-paced environment
• Ability to build and maintain trust and communicate effectively with clients and team members