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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📌 RA Principal Associate (Italia)
🏢 K-Recruiting
📍 Italia