RA Principal Associate
Pubblicato il 16-10-2026 - K-Recruiting in Caserta
RA Principal Associate (M/F/X) Tasks: * Lead and execute regulatory strategies for assigned products and projects. * Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority questions. * Ensure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets. * Provide regional regulatory expertise to support global development, CMC, compliance, and labeling activities. * Liaise with regulatory authorities and support regulatory agency interactions. * Collaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teams. Qualification: * Degree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred).
* Minimum 5+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry. * Strong experience with regulatory submissions and registrations in the EU, UK, and Switzerland. * Experience managing regulatory applications, variations, renewals, and health authority interactions. * Exposure to Veeva and regulatory application management systems is highly desirable. * Experience in vaccines and/or biologics is advantageous. * Strong project management, stakeholder management, and communication skills. * English proficiency is required as all Seqirus business is conducted in English Requirements: Start: Within the next four weeks Duration: 6 months Capacity: 5 days per week Location: Tuscany (IT) #J-18808-Ljbffr