Regulatory Affairs Specialist

RA Officer Specialist

Contracting - Antwerp

Your responsibilities?

• Support regulatory submissions (CTD, BLA, NDA, etc.) by informing site teams of regulatory requirements and drafting the relevant dossier sections
• Liaise with global regulatory colleagues to communicate and resolve potential issues
• Ensure high-quality CMC submissions in compliance with internal and external standards
• Manage responses to Health Authority questions for lifecycle submissions in assigned markets
• Assess and author regulatory variations linked to post-approval changes at the manufacturing site
• Plan and manage activities to meet project timelines and support operational goals

Your Profile:

• Master's degree in Life Sciences (e.g., industrial pharmacy, biomedical sciences, bioengineering)
• Minimum 3 years of experience in the pharmaceutical industry or PhD with regulatory exposure
• Solid experience in regulatory affairs and quality, including authoring CTD and/or BLA
• Strong technical writing, analytical, and scientific reasoning skills
• Knowledge of regulatory guidelines (EMA, FDA) and drug regulations
• Clear communication, negotiation, and interpersonal skills
• Self-driven, adaptable, eager to learn, and team-oriented
• Fluent in written and spoken English

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You're interested in this job? We kindly invite you to apply or send me your CV,