Regulatory Affairs & Pharmacovigilance Manager (Medtech)

TL;DR

Regulatory Affairs & Pharmacovigilance Manager (Medtech): Ensuring global compliance for Expanded Access Programs (EAPs) with an accent on regulatory strategy, dossier submission, and pharmacovigilance oversight. Focus on collaborating with cross-functional teams to streamline drug access while maintaining rigorous quality standards and adherence to international legislation.

Location: Must be based in the Netherlands, United Kingdom, Canada, or the USA. For candidates in North America, must reside within EST or CST time zones.

Company

A global health tech company dedicated to breaking down barriers for patients seeking treatment options through an AI-powered platform.

What you will do

• Develop and execute regulatory strategies for EAPs involving biologicals, cell therapies, and synthetic drugs.
• Act as the primary expert for communications with pharmaceutical clients and Health Authorities.
• Prepare, compile, and submit regulatory dossiers for cohort and named patient programs.
• Liaise with pharmacovigilance service providers to ensure alignment and compliance.
• Maintain department documentation including SOPs, quality incidents, and CAPAs.
• Collaborate with commercial, medical affairs, and supply chain teams to support program execution.

Requirements

• Approximately 5 years of experience in Regulatory Affairs, including Expanded Access.
• Working knowledge of fundamental principles of Pharmacovigilance.
• Bachelor’s or Master’s degree in Life Sciences or a related field.
• Strong communication skills in English (C1 level).
• Must reside in the Netherlands, UK, Canada, or USA (EST/CST time zones for North America).
• Experience working directly with clients or external stakeholders.

Culture & Benefits

• Competitive salary, annual performance bonus, and Employee Stock Option Plan.
• Hybrid working model available for employees in the Netherlands.
• Learning and development budget with internal knowledge-sharing sessions.
• Unlimited access to professional guidance by certified psychologists via OpenUp.
• International work environment with a flat organizational structure.
• Monthly culture events and annual company-wide celebrations.