Lead Regulatory Affairs Specialist
Company: SARACA
- Location: Siena, Italy
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Contract
- Posted: 2 days ago
- Offer language: English
Job description
Language(s): English (Fluent/Proficient required)
Work Schedule: Hybrid (Min. 3 days/week on-site in Siena)
Project Details:
Lead and execute regulatory strategies, submissions, and maintenance for Seqirus vaccine registrations across the EU, UK, and Switzerland. Responsibilities include:
Preparing, compiling, and submitting high-quality regulatory applications (variations, renewals, health authority responses).
Ensuring regulatory dossier compliance across EU, UK, and Swiss markets.
Providing regional regulatory expertise across global development, CMC, compliance, and labeling.
Liaising with regulatory authorities and supporting agency interactions.
Collaborating cross-functionally with QA, Medical, PV, Commercial Operations, and Business Development teams.
Musts:
Minimum 5+ years of Regulatory Affairs experience in Pharma or Biotech.
Degree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field.
Strong experience with regulatory submissions/registrations in the EU, UK, and Switzerland.
Proven track record managing regulatory applications, variations, renewals, and health authority interactions.
Full English language proficiency.
Pluses:
Experience in Vaccines and/or Biologics.
Hands-on experience with Veeva and regulatory application management systems.
Advanced degree in a relevant discipline.
- Strong project and stakeholder management skills.
