Senior Regulatory Affairs Associate

A global biopharmaceutical company is seeking a Regulatory Affairs Contractor to support filings and registration activities across Central Eastern Europe, the Middle East, and Israel. This is a hands-on, operational role ideal for someone with strong EU regulatory experience and familiarity with regional requirements.

🔧 Key Responsibilities:

• Prepare and submit registration dossiers, variations, renewals, and new marketing authorisations.
• Support regulatory filings in the EU, MENA, Turkey, and Israel, using EU dossiers as the reference.
• Navigate RIMS/Veeva systems and manage regulatory documentation.
• Collaborate with cross-functional teams including CMC, QA, and commercial.
• Maintain dashboards and contribute to regulatory information systems.

🎯 Ideal Candidate:

• 3+ years of regulatory affairs experience, with strong knowledge of EU requirements.
• Experience in MENA/Turkey/Israel is a plus.
• Skilled in document management and regulatory systems (RIMS/Veeva).
• Detail-oriented, proactive, and comfortable in a supporting role.
• Strong communication and collaboration skills; soft skills are highly valued.

This is a great opportunity to contribute to impactful work in a dynamic, multicultural environment.

If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at c.siljeur@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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