Regulatory Affairs Manager

About the role

You will own the end to end regulatory strategy and execution for global Expanded Access Programs, translating complex regulatory landscapes into actionable plans for biological, cell therapy, and synthetic drug products. You will serve as the central Regulatory Affairs and Pharmacovigilance expert, shaping how we communicate with pharmaceutical clients and health authorities while ensuring all activities meet the highest standards of compliance. You will partner closely with Medical Affairs, Program Management, Quality Assurance, and Supply Chain to align processes and resolve cross-functional challenges. In this role, you will report directly to the Director of Regulatory Affairs and Pharmacovigilance, contributing to the leadership and integrity of the regulatory function. You will proactively identify potential regulatory or operational hurdles and implement practical solutions that keep programs on track. Your work will directly influence patient access to innovative therapies by ensuring our programs are built on a solid and compliant foundation. You will play a key role in maintaining the quality and consistency of our regulatory and pharmacovigilance documentation across the organization.

Key facts

What you'll do

Support the conception and execution of regulatory strategies for Expanded Access Programs spanning biologicals, cell therapies, and synthetic drugs across multiple jurisdictions.

Act as the primary Regulatory Affairs and Pharmacovigilance liaison for client communications, Health Authority submissions, cross-functional audits, and internal or external meetings requiring regulatory expertise.

Compile, prepare, and submit comprehensive regulatory dossiers for both cohort and named patient Expanded Access Programs on behalf of our client partners.

Provide strategic input for setting up and executing Expanded Access Programs, including recommendations on where, when, and how specific programs should be implemented globally.

Collaborate with the Commercial team to facilitate the setup and launch of new Expanded Access Programs, ensuring regulatory feasibility and alignment.

Ensure all regulatory and pharmacovigilance activities related to Expanded Access Programs are handled in a timely, accurate, and fully compliant manner.

Monitor and interpret evolving global laws, regulations, and guidelines that impact Expanded Access Programs to ensure proactive compliance.

Draft, review, and maintain a wide range of regulatory documentation and templates used across the expanded access workflow.

Coordinate closely with the Pharmacovigilance service provider to ensure seamless alignment, risk management, and regulatory adherence.

Contribute to the maintenance and updating of department documentation, including Standard Operating Procedures, Quality Incidents, and Corrective and Preventive Actions.

Requirements

Bring a minimum of 5 years of professional experience in Regulatory Affairs, with a demonstrated background in Expanded Access Programs and related regulatory environments.

Possess a working knowledge of the fundamental principles and practices of Pharmacovigilance as they apply to expanded access and patient access programs.

Have a solid understanding of national and international legislation, regulations, and guidelines that govern Expanded Access Programs worldwide.

Hold a Bachelor's or Master's degree in Life Sciences or a closely related field from an accredited institution.

Have direct experience working with clients or external stakeholders in a professional setting, demonstrating comfort in regulated discussions.

Exhibit strong written and verbal communication skills in English, with the ability to translate complex regulatory topics for both internal teams and external parties.

Be comfortable collaborating across functions and thriving in a fast-paced, cross-functional team environment.

Approach challenges as a proactive problem solver, identifying potential regulatory or operational risks early and proposing practical, effective solutions.

Be proficient in using Microsoft 365 tools such as Word, Excel, Teams, and SharePoint for daily documentation and collaboration tasks.

Nice to have

Preferred knowledge of additional languages to support our international stakeholders.

Practical notes

Hybrid working model if you are located in the Netherlands.

Equal opportunities

mTomorrows is an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.