Manager, Regulatory Affairs CMC (Cell Therapy)

Location: Hoofddorp, Netherlands

Company

hirify.global is a biopharmaceutical company developing innovative cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.

What you will do

• Lead regulatory CMC activities for assigned clinical and commercial cell therapy programs across Europe and Rest of World countries.
• Develop and execute CMC regulatory strategies aligned with product development stages, regional requirements, and program objectives.
• Author, review, and assess regulatory CMC documentation for accuracy, consistency, and compliance.
• Provide regulatory guidance to cross-functional teams supporting product development, lifecycle management, and commercialization.
• Interpret EMA, EU, Ph. Eur., ICH, and ATMP-specific requirements and assess the regulatory impact of CMC change controls.
• Maintain accurate regulatory IT systems for tracking submissions, statuses, and commitments.

Requirements

• Master’s degree in a life science or technical discipline.
• At least 5 years of relevant Regulatory Affairs CMC experience.
• Knowledge of regional and global regulatory requirements and current Regulatory Affairs CMC trends.
• Experience driving cross-functional deliverables and influencing stakeholders without direct authority.
• Strong written communication skills and experience drafting, reviewing, and editing regulatory, scientific, or technical documents.
• Excellent command of English, written and verbal, is required.

Culture & Benefits

• Work in a biopharmaceutical environment focused on cancer immunotherapies and personalized cell therapies.
• Collaborate with stakeholders across functions, sites, and geographies.
• Operate in a fast-paced environment with changing priorities and strict timelines.
• Work in a culture focused on inclusion, employee development, and accountability.