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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