Regulatory Affair Specialist / Спеціаліст відділу реєстрації
Macleods Pharmaceuticals Limited
We are an international pharmaceutical company that has been developing, manufacturing and supplying a wide range of medicines since 1989. We have our own research and development center and are represented in many countries, including the UK, Spain and the USA. We have been operating in Ukraine since 2005, specializing in products for gastroenterology, pulmonology, cardiology, rheumatology, gynecology/urology, as well as the hospital segment. We are actively developing solutions for the treatment of tuberculosis, influenza, and HIV/AIDS.
Due to expansion, we are announcing a recruitment for the position of Regulatory Affair Specialist
What is important to us:
- Educational Background: A degree in Pharmacy; advanced degrees or certifications in regulatory affairs are often preferred.
- Experience: minimum 1+ years of experience in regulatory affairs, specifically in the registration and compliance of pharmaceuticals and / or food supplements.
- Regulatory Knowledge: Strong understanding of local and international regulatory requirements, experience preparing and submitting regulatory documents, High level of accuracy in documentation, data review, and compliance, ensuring all materials meet regulatory standards.
- Communication Skills: Excellent written and verbal communication skills, with the ability to prepare, review, and submit technical documentation.
- Analytical Skills: Ability to analyze regulatory guidelines and provide strategic advice for regulatory strategies and compliance.
- Problem-Solving Abilities: Skilled in identifying compliance issues and finding solutions, including resolving regulatory concerns and preventing delays in product registration.
- Languages: English - intermediate / upper intermediate
What do we offer:
- Official employment according to the Labor Code;
- High level of remuneration;
- Medical insurance;
- Warm and friendly atmosphere in the team;
- Comfortable office with a generator
We are waiting for you!
E-mail for resume: [email protected]
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