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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)
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