з/п не указана
Москва
От 3 до 6 лет
International Pharmaceutical Company
Responsibilities
- Registration of medicinal products.
- Ensuring the translation of documentation necessary for the submission of dossiers to regulatory authorities.
- Writing drafts of ND (normative documentation) and PIL, preparation of pack artworks with relevant department.
- Execution of documents for payment of state duty.
- Preparation of an electronic application in the required format.
- Submission of documents to regulatory authorities.
- Interaction with experts (correspondence by e-mail, telephone conversations).
- Tracking the status of electronic application.
- Amendment of documents in accordance with the recommendations of regulatory authorities.
- Regular information the management about the stages of registration and changes required.
- Tracking the correctness of the information entered in the State Register of Medicines.
Qualification & experience:
- High pharmaceutical, chemical biological, or medical education.
- 2+ year of similar experience in reputed pharmaceutical company.
- Knowledge of Russian Regulation in the field of medicines circulation.
- Fluency in English (business correspondence, communications &presentations).
- Personal computer skills (MS Office).
Сonditions can be discussed.
