Regulatory Affairs Pharmacovigilance Manager

myTomorrows B.V.

Job Overview

Location

US, Remote

Job Type

Full-time

Full Job Description

📋 Description

• Lead the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs to ensure global compliance.
• Serve as the primary Regulatory Affairs and Pharmacovigilance expert for communications with pharmaceutical clients and submissions to Health Authorities worldwide.
• Prepare, compile, and submit regulatory dossiers for cohort and named patient EAPs on behalf of clients, ensuring accuracy and adherence to country-specific regulations.
• Provide strategic input on the setup and execution of EAPs, including geographic, timing, and procedural considerations aligned with regulatory requirements.
• Collaborate with the Commercial team to support the launch and scaling of new Expanded Access Programs.
• Ensure timely and fully compliant handling of all regulatory and pharmacovigilance activities tied to EAPs across multiple jurisdictions.
• Maintain current knowledge of global laws, regulations, and guidelines affecting Expanded Access programs and apply them to operational processes.
• Draft, review, and maintain regulatory documentation, templates, and standard operating procedures (SOPs) to ensure consistency and audit readiness.
• Liaise with the external Pharmacovigilance service provider to ensure alignment on safety reporting, signal detection, and regulatory compliance obligations.
• Contribute to the maintenance of departmental quality documentation including Quality Incidents (QIs) and Corrective and Preventive Actions (CAPAs).
• Act as a key point of contact in cross-functional meetings with Medical Affairs, Program Management, Quality Assurance, and Supply Chain teams.
• Communicate complex regulatory and pharmacovigilance concepts clearly and effectively to both internal teams and external stakeholders in English.
• Proactively identify potential regulatory or operational risks in EAP execution and propose practical, compliant solutions.
• Utilize Microsoft 365 tools (Word, Excel, Teams, SharePoint) to manage documentation, collaborate across teams, and support regulatory submissions.

🎯 Requirements

• 5 years of relevant experience in Regulatory Affairs, including direct experience with Expanded Access Programs
• Working knowledge of fundamental Pharmacovigilance principles
• Solid understanding of national and international regulations governing Expanded Access
• Bachelor’s or Master’s degree in Life Sciences or a related field
• Experience working directly with external clients or stakeholders in a professional capacity
• Strong written and verbal communication skills in English

🏖️ Benefits

• Impactful work enabling patient access to potentially lifesaving treatments
• Competitive salary with annual performance bonus and Employee Stock Option Plan
• Learning and development budget with internal knowledge sharing sessions
• Unlimited access to professional psychological guidance via OpenUp
• Monthly Culture Club events and annual company-wide ‘myTomorrowland’ celebration
• Policies supporting working parents

Skills & Technologies

Remote

Degree Required

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myTomorrows B.V.

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About myTomorrows B.V.

myTomorrows B.V. operates an Amsterdam-based platform that connects physicians and patients worldwide with pre-approval and off-label medicines. The company identifies investigational or licensed drugs not yet commercially available in a patient’s country, navigates regulatory pathways, arranges supply, and supports pharmacovigilance. It serves oncology, neurology, and rare diseases, working with pharmaceutical companies, hospitals, and regulators in Europe, North America, and Asia-Pacific.

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