Вакансия находится в АРХИВЕ.
Regulatory Affairs Manager
Москва
Responsibilities:
- To review of regulatory documentation prepared by global regulatory department and by business partners, identify gaps and achieve their elimination
- To prepare local normative documents (ND) and packaging texts
- Preparation of dossier for submission according to national and EAEU legislation
- To track regulatory procedure in the state register
- To submit all requested samples and standards to laboratory
- Communication with regulatory contacts in Headquarter (HQ) for obtaining necessary documents and materials, negotiations in case of any specific cases/issues
- To ensure that product information and packaging materials are updated with the most recent corporate and local requirements at any time
- Maintenance of the regulatory data bases and files
- EAEU legislation review, taking part in workshops on EAEU regulation and taking part in building of the new regulatory submission strategy
- Checking and approval of PROMO materials on behalf of RA department
- Preparing of registration documentation for GMP inspections
- Chemical/Pharmaceutical/Medical University Degree
- Experience in regulatory affairs in local or foreign company
- In-depth knowledge of regulations/legislation (Russia and EAEU)
- Good knowledge of written and spoken English (intermediate or higher)
- Salary above the market conditions
- Annual bonus programm
- Healthcare and life insurance
- Convinient accomodation of the office
10 сентября 2019
От 1 года до 3 лет
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