RA Principal Associate

RA Principal Associate – Italy – Initial 6-Month Contract – Life Sciences

Our client is a global biopharmaceutical company manufacturing plasma-derived, and recombination therapeutic products, who in turn deliver high-quality medicines that treat people with rare and serious diseases, and we are now searching on an exclusive basis with the client to appoint an RA Principal Associate to support their busy and rewarding team on a contractual basis for a period of 6 months.

What you’ll deliver:

• 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.

Key requirements include:

• Degree in Biological Sciences, Pharmacy, Allied Medical Discipline, or related field (advanced degree preferred).
• Extensive 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.

If this role is of interest, please apply now!

#LI-KT1