Senior Specialist, Regulatory Registration and Compliance

Responsibilities

• Prepare and manage marketing authorization (MA) submissions, including local administrative documents, quality control, and compilation
• Provide ad hoc regulatory advice on submission packages in the post-authorization stage
• Review and provide linguistic input for local Product Information and Mock-ups
• Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities and clients
• Manage the network of local contact persons for Regulatory affairs
• Collect and manage regulatory intelligence to inform the organization of key updates
• Propose marketing authorization strategies tailored to client needs
• Act as a deputy for the line manager when required

Requirements

• University education in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology
• Previous pharmaceutical industry experience
• Knowledge of Regulatory (EU) area and applicable legal requirements
• Excellent organizational and project management skills
• Strong communication skills for client and regulatory body liaison
• Advanced English proficiency (written and verbal)

Preferred Qualifications

• Experience with centralised procedures
• Experience with regulatory databases and dossier management software

About the Company

PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision.