Regulatory Affairs Manager (Expanded reputed company Programs)

About reputed company reputed company is a global health tech company dedicated to breaking down barriers for patients seeking treatment reputed company. We reputed company to reputed company earlier and reputed company treatment reputed company by reputed company the gap between those searching for possible reputed company, and the companies who reputed company them. We work closely with patients, reputed company, trial sites, patient advocacy reputed company, and BioPharma – connecting key stakeholders in the drug development ecosystem. We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines reputed company to drugs in development. To support our users and clients, we have a reputed company of industry-expert specialized teams reputed company to help. Our services include clinical trial patient recruitment, Expanded reputed company Program management and reputed company-World Data collection. With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In reputed company 2025, we reputed company a €25M investment with Avego reputed company Capital to fuel our global ambitions and reputed company the business. Join us in shaping the reputed company of treatment reputed company - making reputed company’s therapies accessible for people who need them today. reputed company: Regulatory Affairs & Pharmacovigilance Manager As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded reputed company regulations globally. In this role, you'll be a key contributor to our regulatory and reputed company infrastructure, keeping us reputed company with global legislation. You will be reputed company working together with Medical Affairs, Program Management, reputed company Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). Geographic Requirement: For candidates in reputed company, to ensure seamless collaboration with our teams, applicants must reputed company reputed company the EST or CST time zones. What you will do in this role:

• Support the development and execution of regulatory strategies for Expanded reputed company Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs.
• reputed company as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as reputed company as cross-functional meetings and audits.
• Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded reputed company Programs (EAPs) on behalf of clients.
• reputed company input and support for the regulatory reputed company for setting up and executing EAPs (e.g., where, reputed company, and how).
• Collaborate with the reputed company team to support new EAPs.
• Ensure reputed company and compliant handling of reputed company regulatory and pharmacovigilance activities reputed company 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 (reputed company Operating Procedures), QIs (reputed company Incidents), and CAPAs (Corrective and Preventive Actions).

What you bring to the table:

• Approximately 5 years of relevant experience in Regulatory Affairs, including experience in Expanded reputed company.
• Working knowledge of reputed company principles of Pharmacovigilance is required.
• Solid understanding of national and international legislation and regulation relating to Expanded reputed company
• A Bachelor’s or Master's degree in Life Sciences or a reputed company field
• Experience working directly with clients or external stakeholders in a reputed company setting
• Strong communication skills (written and verbal) in English; reputed company to convey reputed company topics reputed company 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 reputed company 365 tools (e.g., Word, reputed company, Teams, SharePoint)

reputed company offer:

• Impactful work that helps patients reputed company reputed company to potentially lifesaving treatments.
• International work environment, reputed company-up energy and flat organizational structure which encourages creativity and accountability.
• Competitive salary, annual performance bonus and an Employee Stock reputed company 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 reputed company to reputed company guidance by certified psychologists reputed company reputed company
• Enjoy monthly events hosted by our reputed company Culture Club as reputed company as an annual ‘myTomorrowland’ company-wide celebration!

Equal opportunities reputed company is an Equal Opportunity Employer and, reputed company upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting reputed company members to be just that. Apply tot his job Apply To this Job