Regulatory Affairs Officer / Specialist

About the role

The Regulatory Affairs Officer / Specialist will support the regulatory function across Europe and CIS markets. You will coordinate submissions, manage documentation, and ensure compliance with national and European legislation.

Key responsibilities

• Provide support during external and unannounced audits.
• Respond to internal requests for technical and regulatory information.
• Assist with license applications, variations, renewals, MAH transfers, and technical/site transfer applications.
• Prepare and submit documentation for post‑approval activities, including marketing authorisation applications.
• Monitor and maintain up‑to‑date knowledge of national, European and CIS guidelines.
• Manage artwork generation, labelling, and product information updates.
• Upload local product information to national patient/HCP websites.
• Coordinate variation, renewal, PSUR, CPP, and safety update procedures.

Required profile

• Degree in a relevant life‑science discipline.
• 5‑15 years of regulatory experience in Europe and CIS markets.
• Experience in people management or coordination.
• Proven ability to meet tight timelines without compromising quality.

Required skills

• Microsoft Office Suite
• Veeva Vault (or comparable EDMS)
• LorenZ
• Trackwise
• PromoMat

What we offer

• Opportunity to work on diverse regulatory projects across multiple countries.
• Collaborative environment with a focus on professional development.