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Regulatory manager

NAARI
4 года назад
09 сентября 2019
Киев

World-leading pharmaceutical company is looking for Regulatory Manager.

Required Qualifications, Skills and Experiences

  • Pharma Graduate/ Post Graduate
  • 3-5 years of experience in pharma regulatory affairs
  • Good English speaking skills
  • Good communications & interpersonal skills
  • Good in building long term relationships
  • Having a very structured way of working
  • Team Management
  • Effective Coordination skills
  • Planning & Organizing skills
  • Proficient in MS Office (word, excel, power point)

Key Responsibilities:

  • Responsible for registration of already approved products in Ukraine
  • Responsible for GMP Certification of manufacturing facility.
  • Responsible for GMP confirmation of manufacturing facility already approved by PIC/s member state
  • Responsible for arranging the updated registration guidelines for preparation of registration dossiers.
  • Responsible to review the registration dossiers/documents before submission to MOH
  • Responsible for translation of documents and artworks for MOH submission
  • Responsible for submitting the dossier/documents to MOH for registration/ re-registration.
  • Responsible for following up with various regulatory authorities for timely registration of products
  • Responsible for approval of artworks for commercialization
  • Responsible for preparation of weekly/monthly work reports
  • Responsible for reviewing and preparation of pharmacovigilance documents (PSUR, RMP and PSMF) and its submission in MOH Ukraine.
  • Responsible for Local qualified person for pharmacovigilance. (LQPPV)
  • Responsible for registration of drug products, food supplements, cosmetics and medical devices at MOH, Ukraine

 

Екатерина Добудько

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