Regulatory Affairs Manager

Job Summary

As a full-time Regulatory Affairs Manager focused on Expanded Access Programs, the successful candidate will ensure compliance with global regulations, develop regulatory strategies, and manage communications with clients and health authorities while working remotely.

Key responsibilities

• Support the development and execution of regulatory strategies for Expanded Access Programs involving biologicals and synthetic drugs
• Act as the expert for regulatory communications and submissions to health authorities, as well as cross-functional meetings and audits
• Prepare and submit regulatory dossiers for cohort and named patient Expanded Access Programs 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