Код вакансии: 68542928b1900300356a1dab
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- Москва
Regulatory Affairs Manager
The person will:
- Ensure new registrations/line extensions according to BI strategy (full cycle);
- Maintain existing Marketing Authorizations in RU by ensuring timely submissions of variations/renewals;
- Communicate with Regional/Corporate RRA to ensure receipt of the relevant registration data and samples;
- Maintain BI systems and databases in accordance with local responsibilities;
- Ensure compliance of approved registration documents (ND, PIL, artworks) with marketed products;
- Maintain of PSUR/DSUR/RMP management in accordance with local WI.
Our requirements:
- Diploma Degree (Biopharmaceuticals, Biochemistry, Chemistry, Pharmacy);
- Relevant Experience in RA;
- High level of familiarity with the regulatory procedures;
- Strong understanding of the company’s needs and ability to transform these into appropriate regulatory activities;
- Advanced organizational, analytical, strategic skills with decision making capabilities;
- Excellence at communication and negotiation;
- English – Intermediate.