Europe & Business Development Regulatory Affairs Specialist

About the role

The Europe & Business Development Regulatory Affairs Specialist will manage regulatory activities for overseas markets, preparing and submitting licensing documents, coordinating with internal departments, and ensuring compliance with local regulations. This position reports to the Europe & Business Development Regulatory Affairs Team Lead.

Key responsibilities

• Prepare and translate license applications and renewals into English for submission to health authorities in each country.
• Coordinate document tracking and respond to authority inquiries by liaising with R&D, Quality, Production, Foreign Trade, Purchasing, Import, and Patent departments.
• Monitor country-specific regulations and update files to meet local requirements.
• Ensure proper preparation and dispatch of documentation in accordance with established procedures.
• Track process execution by communicating with country teams to guarantee compliance.

Required profile

• Graduated from Pharmacy, Chemical Engineering, Chemistry, Biology, Molecular Biology/Genetics or a related field.
• Minimum of 2 years experience in regulatory affairs.
• Proficient in written and spoken English.