Regulatory Affairs Pharmacovigilance Manager

About the position reputed company is a global health tech company dedicated to breaking down barriers for patients seeking treatment options. We strive to reputed company earlier and reputed company treatment reputed company by bridging the gap between those searching for possible options, and the companies who reputed company them. We work closely with patients, reputed company, trial sites, patient advocacy groups, 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 closed a €25M investment with Avego reputed company Capital to fuel our global ambitions and scale the business. Join us in shaping the future of treatment reputed company - making reputed company’s therapies accessible for people who need them today.

Responsibilities

• Support the development and execution of regulatory strategies for Expanded reputed company 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 reputed company Programs (EAPs) on behalf of clients.
• reputed company input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, reputed company, and how).
• Collaborate with the reputed company team to support new EAPs.
• Ensure timely 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 (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 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 professional 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.
• 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-to-haves

• Knowledge of additional languages is a plus

Benefits

• Competitive salary
• annual performance bonus
• Employee Stock Option Plan
• Great career development opportunities in a fast-growing company.
• Learning and development budget
• 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 professional guidance by certified psychologists reputed company reputed company
• monthly events hosted by our vibrant Culture Club
• an annual ‘myTomorrowland’ company-wide celebration!

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