Regulatory Affairs Manager
Company: SARACA
- Location: Siena, Italy
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
Language: English (Fluent/Proficient required)
Work Schedule: Hybrid – Minimum 3 days per week onsite in Siena, Italy
Project Overview
Lead and execute regulatory strategies, submissions, and maintenance activities for vaccine registrations across the EU, UK, and Switzerland.
Key Responsibilities
- Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority queries.
- Ensure regulatory dossier compliance across EU, UK, and Swiss markets.
- Provide regional regulatory expertise across global development, CMC, compliance, and labeling activities.
- Liaise with regulatory authorities and support agency interactions.
- Collaborate cross-functionally with QA, Medical, Pharmacovigilance (PV), Commercial Operations, and Business Development teams.
Must-Have Requirements
- Minimum 5+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
- Degree in Biological Sciences, Pharmacy, an Allied Medical Discipline, or a related field.
- Strong experience with regulatory submissions and product registrations across the EU, UK, and Switzerland.
- Proven track record managing regulatory applications, variations, renewals, and health authority interactions.
- Full professional proficiency in English.
Preferred Qualifications
- Experience in vaccines and/or biologics.
- Hands-on experience with Veeva and regulatory application management systems.
- Advanced degree in a relevant discipline.
- Strong project management and stakeholder management skills.
