Regulatory Affairs Specialist

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a Regulatory Affairs Specialist, you interpret federal, state, and international regulations and translate them into applicable requirements for products, processes, and procedures.
• You manage product registration activities for assigned products and support the introduction of new products. 
• you author and support regulatory submissions (CTD, BLA, NDA, CMC) and inform site stakeholders or regulatory requirements. 
• You liaise with global and local regulatory colleagues to align, communicate, and resolve regulatory issues. 
• You collaborate cross-functionally with manufacturing, labs, QA, supply, R&D, and global regulatory teams. 
• You ensure high-quality and compliant CMC submissions.
• You manage timely responses to health authority questions related to lifecycle submissions. 
• You assess post-approval changes and author impacted dossier sections and regulatory variations. 
• You contribute to project delivery by managing priorities, timelines, and work plans to meet operational goals. 

Requirements

• Master civil, industrial, or bio-engineer, industrial pharmacist, or equivalent through experience. 
• Experience in the pharmaceutical industry and GMP environment. 
• Knowledge of risk assessment, verification, and validation. 
• Strong analytical and problem-solving skills. 
• Pragmatic and proactive mindset. 
• Ability to take the lead and motivate others. 
• Strong communication and interpersonal skills. 
• Strong technical writing skills. 
• Experience with engineering (CAPEX) projects and project coordination. 
• MS project experience is a plus. 
• Fluent in Dutch and English. 

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.