Regulatory Affairs Manager – Expanded Access Programs

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Assist in the formulation and implementation of regulatory strategies for Expanded Access Programs (EAPs) that involve biological products, cell therapies, and synthetic pharmaceuticals.

• Serve as the expert in Regulatory Affairs and Pharmacovigilance for client communications (pharmaceutical companies) and for submissions to Health Authorities, as well as for cross-functional meetings and audits.

• Prepare, compile, and submit regulatory documentation for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients.

• Provide insights and assistance for the regulatory strategy concerning the establishment and execution of EAPs (e.g., determining the locations, timing, and methods).

• Work collaboratively with the Commercial team to facilitate new EAPs.

• Ensure that all regulatory and pharmacovigilance activities related to EAPs are managed in a timely and compliant manner.

• Stay informed about relevant global laws, regulations, and guidelines that affect EAPs.

• Assist in drafting, reviewing, and updating regulatory documents and templates.

• Coordinate with the Pharmacovigilance service provider to ensure consistency and compliance.

• Help maintain departmental documentation such as Standard Operating Procedures (SOPs), Quality Incidents (QIs), and Corrective and Preventive Actions (CAPAs).

⛳️ Requirements

• Approximately 5 years of relevant experience in Regulatory Affairs, with a focus on Expanded Access.

• A working knowledge of the fundamental principles of Pharmacovigilance is essential.

• A strong grasp of national and international laws and regulations pertaining to Expanded Access.

• A Bachelor’s or Master's degree in Life Sciences or a related discipline.

• Experience engaging directly with clients or external stakeholders in a professional environment.

• Excellent communication skills (both written and verbal) in English; capable of articulating complex subjects clearly to both internal teams and external entities. Proficiency in additional languages is an advantage.

• Comfortable working collaboratively across teams in a cross-functional setting.

• A proactive problem solver with the capacity to identify potential regulatory or operational issues early and propose effective solutions.

• Familiarity with Microsoft 365 applications (e.g., Word, Excel, Teams, SharePoint).

🏝️ Benefits

• Engaging work that aids patients in accessing potentially life-saving treatments.

• An international work atmosphere with a dynamic startup culture and a flat organizational structure that fosters creativity and accountability.

• Competitive salary, annual performance bonuses, and an Employee Stock Option Plan.

• Excellent career advancement opportunities within a fast-growing company.

• A budget for learning and development, along with internal knowledge-sharing sessions.

• A hybrid working model for employees based in the Netherlands.

• Supportive policies for working parents.

• Healthy lunch options available at the vibrant Amsterdam office.

• Unlimited access to professional support from certified psychologists via OpenUp.

• Monthly events organized by our lively Culture Club, as well as an annual company-wide celebration called ‘myTomorrowland’!