Regulatory Affairs, Pharmacovigilance Manager

Job reputed company:

• 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).

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 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)

Benefits:

• 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!

Apply To This Job