Regulatory Affairs Specialist

About This Role

This role as a Regulatory Strategist involves playing a key part in the registration and lifecycle management of pharmaceutical products within an international setting. You will support the introduction of new products and ensure compliance with global regulations, working closely with various internal and international teams to create high-quality CMC submissions.

Responsibilities

• Prepare and support regulatory submissions (CTD, BLA, NDA, and CMC dossiers)
• Advise internal stakeholders on regulatory requirements
• Collaborate with international regulatory teams to submit dossiers in a timely and compliant manner
• Respond to inquiries from health authorities regarding lifecycle submissions
• Evaluate post-approval changes and prepare the associated regulatory variations
• Contribute to operational and project objectives within multidisciplinary teams

Requirements

• Master's degree in Life Sciences (e.g., Pharmaceutical Sciences, Biomedical Sciences, Bioengineering)
• Minimum of 3 years of experience in the pharmaceutical sector or equivalent via a PhD
• Experience with regulatory affairs, CTD, BLA, and CMC documentation
• Knowledge of EMA, FDA, and other relevant pharmaceutical regulations
• Strong technical writing skills and analytical insight
• Fluent communication in Dutch and English

Benefits

• Permanent contract from day one
• Net allowance
• Premium company car with fuel or charging card
• Group and hospitalization insurance
• Meal vouchers (€8/day) and eco-vouchers (€250/year)
• 12 ADV days
• Training, career development opportunities, and personal guidance from a Career Manager

About the Company

Science Talents combines the security of a permanent contract with challenging projects at leading companies, personal guidance, and ample opportunity for self-development. The company creates a warm, inclusive community where everyone feels welcome and has the space to fully utilize their talents, with equality at its core.