Ra principal associate
Pubblicato il 17-10-2026 - K-Recruiting in Italia
H3RA Principal Associate (M/F/X) /h3 h3Tasks: /h3 ul lipLead and execute regulatory strategies for assigned products and projects. /p /li lipPrepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority questions. /p /li lipEnsure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets. /p /li lipProvide regional regulatory expertise to support global development, CMC, compliance, and labeling activities. /p /li lipLiaise with regulatory authorities and support regulatory agency interactions. /p /li lipCollaborate with cross-functional stakeholders including Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations, and Business Development teams. /p /li /ul h3Qualification: /h3 ul lipDegree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred).
/p /li lipMinimum 5+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry. /p /li lipStrong experience with regulatory submissions and registrations in the EU, UK, and Switzerland. /p /li lipExperience managing regulatory applications, variations, renewals, and health authority interactions. /p /li lipExposure to Veeva and regulatory application management systems is highly desirable. /p /li lipExperience in vaccines and/or biologics is advantageous. /p /li lipStrong project management, stakeholder management, and communication skills. /p /li lipEnglish proficiency is required as all Seqirus business is conducted in English /p /li /ul h3Requirements: /h3 pbStart /b: Within the next four weeks /p pbDuration /b: 6 months /p pbCapacity /b: 5 days per week /p pbLocation /b: Tuscany (IT) /p #J-18808-Ljbffr