Regulatory Affairs Specialist

International original pharmaceutical company is looking for Regulatory Affairs Specialist.

Responsibilities:

• Monitor the regulatory environment and ensure legislation compliance in Ukraine. Monitor regulatory environment and ensure full compliance with relevant legislation and internal SOPs. Interact constantly with Health Authorities (HAs) to ensure timely approvals, detect regulatory trends and keep up-to-date with legislation at affiliate;
• Coordinate and handle Regulatory Affairs Processes related to NDA and LCM in Ukraine. Medicinal products: registration submissions (new registrations, renewals, variations) and preparation documents for submission (dossiers, PILs, MQCs, labelling text, mock-ups etc). 
• Ensure timely submission and follow-up of variations to the local HAs, in cooperation with the key stakeholders;
• Medical devises handling: registration, annual supervising audits arrangement, communication with the local Assessment Bodies;
• To ensure getting local GMP acknowledgement in Ukrainian HAs according to local regulatory requirements. GMP recognition in Ukraine (dossier preparation, documents` translation, handling negotiation with HQ representatives).

Requirements: 

• Higher pharmaceutical education preferred
• 1-2 years of experience in regulatory affairs
• Knowledge of medicines registration legislation (Ukraine)
• English upper Intermediate
•  Attentive to details.