Regulatory Affairs Manager

Job Summary

As a full-time Regulatory Affairs and Pharmacovigilance Manager working remotely, the successful candidate will ensure compliance with global expanded access regulations, support regulatory strategies for programs, and act as an expert in communications with clients and Health Authorities.

Key responsibilities

• Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs)
• Act as the Regulatory Affairs and Pharmacovigilance expert for client communications and regulatory submissions
• Prepare and submit regulatory dossiers for cohort and named patient EAPs on behalf of clients

Required qualifications

• Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access
• Working knowledge of fundamental principles of Pharmacovigilance
• Solid understanding of national and international legislation relating to Expanded Access
• A Bachelor's or Master's degree in Life Sciences or a related field
• Experience working directly with clients or external stakeholders in a professional setting