Original listing text, shown exactly as published by the company.
The opportunity: 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 access regulations globally. In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation. You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi).
What you will do in this role
- 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).
What you bring to the table
- 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)
