Global Regulatory Affairs Associate (m/w/d) – Siena

About the role

We make it GmbH, a Swiss national personnel services company, is recruiting on behalf of CSL Seqirus, one of the world's largest influenza vaccine companies, for a Global Regulatory Affairs Associate based in Siena. The position lasts 6 months with standard working hours of 41 hours per week.

Key responsibilities

• 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
• Keep regulatory dossiers compliant and up to date for the 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 Regulatory Affairs, Quality, Medical, Pharmacovigilance, Commercial Operations and Business Development teams

Required profile

• Degree in Biological Sciences, Pharmacy, an Allied Medical Discipline or a related field (advanced degree preferred)
• At least 5 years of regulatory affairs experience in 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
• English proficiency is required, as all Seqirus business is conducted in English

Required skills

• 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

Applications are sent by e-mail to the recruiter, Mr. Raphael Sigg, with CV, certificates and training certificates attached.