Our client is an international pharmaceutical company, one of the world leaders in the generic medicines segment and represented in over 150 countries. In connection with the expansion is looking for Regulatory Affairs Specialist, Kyiv.
Regulatory Affairs Specialist, Kyiv
Education:
University Degree
Work experience:
2+
Working hours:
Full-time, hybrid
Description of a vacancy
Requirements:
- University Degree in Pharmaceutical, Medical, Chemical or related;
- Similar experience from 2 years;
- Intermediate and above English (B1 - B2);
- Knowledge of legislation and regulatory medicinal products requirements;
- Confident command of MS Office, Excel / Power Point / Coral Draw;
- Attentiveness, responsibility, ability to adhere to established deadlines when completing the task.
We offer:
- Official employment, competitive salary and annual bonus;
- Hybrid work format (by agreement);
- Comfortable office near the Osokorky metro station, corporate mobile communication and laptop;
- Professional development, corporate training and opportunities for career growth within the company.
Responsibilities:
- Preparation and support of registration, re-registration and amendments to registration materials of medicines;
- Formation and maintenance of registration dossier (eCTD) in accordance with the requirements of the legislation of Ukraine;
- Interaction with regulatory authorities, laboratory control and support of registration procedures;
- • Communication with the head office regarding documentation, approval of packaging materials and instructions;
- Preparation of documents for GMP, reporting and monitoring of regulatory processes.