Job Description:
• Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
• Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits.
• Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients.
• Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how).
• Collaborate with the Commercial team to support new EAPs.
• Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs.
• Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs.
• Assist in drafting, reviewing, and maintaining regulatory documentation and templates.
• Liaise with the Pharmacovigilance service provider to ensure alignment and compliance.
• Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions).
Requirements:
• Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded Access.
• Working knowledge of fundamental principles of Pharmacovigilance is required.
• Solid understanding of national and international legislation and regulation 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
• Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus
• Comfortable collaborating across teams and working in a cross-functional environment
• Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions
• Familiarity with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint)
Benefits:
• Impactful work that helps patients gain access to potentially lifesaving treatments.
• International work environment, scale-up energy and flat organizational structure which encourages creativity and accountability.
• Competitive salary, annual performance bonus and an Employee Stock Option Plan.
• Great career development opportunities in a fast-growing company.
• Learning and development budget alongside internal knowledge sharing sessions.
• Hybrid working model if you're in the Netherlands.
• Policies to support working parents.
• Healthy lunch at the thriving Amsterdam office.
• Unlimited access to professional guidance by certified psychologists via OpenUp
• Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ company-wide celebration!