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
Requirements:
  • 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)
Company offers:
  • Salary above the market conditions
  • Annual bonus programm
  • Healthcare and life insurance
  • Convinient accomodation of the office

28 июня 2019
10 июля 2019
От 1 года до 3 лет

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