Medicinal Products Registration Specialist (Project-Based, Remote)

Send your CVs to contact person.

Please pay attention that the European Business Association, registered at Kniaziv Ostrozkykh, building 7, 01029, Kyiv, Ukraine, identification code of legal entity 31811085, neither collects nor in any other way processes your personal data, submitted to the contact person within this vacancy announcement. In order to receive information required by law, in particular on the data controller and purposes of data processing in such cases, etc., please get in touch with the contact person mentioned above.

Requirements:

• Higher education in Pharmacy, Biotechnology, Chemistry, Biology, or related fields.
• At least 2 years of practical experience in Regulatory Affairs.
• Experience in the preparation and maintenance of medicinal product registration dossiers.
• Practical knowledge of CTD/eCTD structure and requirements.
• Experience in communication with manufacturers and preparation of regulatory documentation.
• Knowledge of the current Ukrainian legislation and regulatory requirements for the state registration of medicinal products.
• Proficient user of Microsoft Office applications.
• English language proficiency at Intermediate+ level (ability to work with documentation and conduct professional correspondence).

Responsibiities:

Regulatory Support of Registration Projects

• Preparation and maintenance of medicinal product registration dossiers for state registration in Ukraine.
• Compilation and review of CTD/eCTD documentation in accordance with current regulatory requirements.
• Coordination of registration documentation preparation with internal departments and manufacturers.
• Control of the completeness, compliance, and quality of documents prior to submission.

Registration Dossier Management

• Review and analysis of manufacturers' registration documentation.
• Preparation of the Ukrainian part of the registration dossier.
• Development of lists of missing documents and coordination of their collection.
• Maintenance of up-to-date registration dossier versions throughout the project lifecycle.

Interaction with Manufacturers

• Communication with international manufacturers regarding the provision of required regulatory documentation.
• Coordination of document revisions and responses to regulatory inquiries.
• Support of the approval process for artwork, specifications, and other documents within registration projects.

Regulatory Agency Communication and Registration Process Support

• Preparation of responses to comments and requests from regulatory authorities.
• Management of the state registration process through to the final approval decision.
• Coordination of dossier updates in accordance with received regulatory comments.

Project Administration

• Monitoring the status of registration procedures.
• Maintaining document registers and tracking project deadlines.
• Preparation of regular project progress reports

We offer:

• Fully remote position.
• 12-month contractual assignment with the possibility of extension.
• Project-based role focused on regulatory registration dossier management.
• Flexible working hours, subject to meeting agreed project timelines and deliverables.
• Regular online collaboration with internal teams and international manufacturers.

Employment type:

• Fully remote position.
• Full-time engagement.

Location:

Kyiv, Akademika Knyshova Street.