Regulatory Trainee

Our Client - global healthcare company, which operates in Ukraine for more than 20 years, with specialization in original and genetic medicines for treatment of diabetes, cardiovascular, gastroenterological and oncological diseases, etc. is looking for a Regulatory Trainee:

Main Duties:

· Contributes to the administration of the new authorizations / renewals / line extensions / therapeutic indications / variation procedures, in accordance with the global strategy, the needs of the branch and the national regulations, including personal submissions to Health Authorities.

· Ensures the maintenance / update of the allocated marketing authorizations, in accordance with the company's global strategy and local regulations.

· Provides support to other departments, regarding the launch plan, the planning of variations, the implementation of changes in the market, the discontinuation of some products on the market.

· Ensures that Labels, instructions for medical use and artworks are up-to-date and accurate.

· Performs the preparation of specific packaging materials in Ukrainian, ensures that the approved texts are sent promptly to the manufacturing sites and that the final validation is in accordance with the approvals obtained.

· Fills in the company's databases in accordance with internal procedures.

· Provides support to other affiliate members on regulatory issues

· Maintains and develops optimal relationships with competent authorities and decision makers.

· Performs any task assigned by RA CHC Lead, in accordance with professional experience and expertise.

· Contributes to the archiving process as per local procedures. 

Background and Skills: 

· Student status or university graduate (preferred fields: life sciences (pharmaceuticals, biochemistry, medicine, biotechnology etc.))

· Willingness to develop and learn, high level of commitment and readiness to work in a dynamic environment

· In-depth knowledge of current regulations and practice, related to the norms and regulations in Ukraine

· Proactivity and independence in finding solutions

· Communication, openness, and positive energy

· Very good knowledge of English and Ukrainian

· Knowledge of MS Office (Outlook, MS Excel and PowerPoint)

What We Offer:

• Official full-time employment (contract for 6 months, may be prolonged to 1 year with possible further professional development)
• Competitive market remuneration 
• Hybrid work (mostly in Kyiv office – city’s center, near Olimpiiska Station)
• Team of professionals with deep market expertise to work with