Senior Project Manager, Regulatory Affairs

Job Summary

Providing management and leadership for high-quality projects, the full-time Senior Project Manager, Regulatory Affairs will work remotely to interface with internal departments, company leadership, sponsors, and vendors while integrating consulting activities across various areas of expertise.

Key responsibilities

• Plan, prepare, and execute regulatory affairs projects in collaboration with cross-functional teams
• Interface with internal stakeholders and external partners to ensure project alignment and success
• Integrate consulting activities across CMC, quality, regulatory, clinical, and business areas

Required qualifications

• Bachelor's degree in life/health sciences or a related discipline
• 6 to 8 years of relevant regulatory experience in a Clinical Research Organization or Pharmaceutical Company
• Minimum of 3 years of Project Management or functional team lead experience
• Good working knowledge of drug development processes and regulatory requirements, including ICH guidelines
• Proficiency in English (written and verbal)