18 ott - Toscana
K-Recruiting Life Sciences
- 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.
Required Experience & Qualifications:
- 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
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