mytomorrows - Regulatory Affairs Manager (Expanded Access Programs)
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)
Responsibilities
• 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).
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! • Equal opportunities
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