Regulatory Affairs Pharmacovigilance Manager
Remote · United Kingdom or United States
Job Summary
Regulatory Affairs & Pharmacovigilance Manager responsible for ensuring compliance with country-specific expanded access regulations globally; develop and execute regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs; act as RA and Pharmacovigilance expert for client communications and regulatory submissions to Health Authorities; prepare and submit regulatory dossiers for EAPs; collaborate across cross-functional teams (Medical Affairs, Commercial, QA, Supply Chain); maintain regulatory documentation and templates; stay current on global laws and guidelines; contribute to SOPs, QIs, and CAPAs; hybrid work model if in the Netherlands; extensive interaction with clients/external stakeholders.
Required Qualifications
- Bachelor's or Master's degree in Life Sciences or a related field
- Approximately 5 years of relevant experience in Regulatory Affairs, including Expanded Access
- Working knowledge of Pharmacovigilance principles
- Strong understanding of national and international legislation related to Expanded Access
- Experience with regulatory communications with clients and Health Authorities
- Proactive problem solver with ability to identify regulatory/operational challenges early
- English fluency; additional languages a plus
- Microsoft 365 proficiency
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