Обязанности:
Требования к квалификации:
Образование: высшее
Условия работы:
- lead the strategy of regulatory events,
- manage the team for dossier preparation and submission of registration, renewal and variation dossiers and answers to the CA questions,
- directly in charge of some products, manage the dossiers under his/her responsibility: EAEU registrations/alignments, EAEU/national variations, renewals,
- organization of work for Russian and EAEU MA files constitution for medicines registration/renewals/variations,
- organization of work for Russian and EAEU pharmaceutical documents' writing (SmPC, PIL, Normative Documents),
- organization of answers preparation for Competent Authorities' requests,
- regulatory intelligence supervision.
Требования к квалификации:
- higher education in pharmacy, medicine or life sciences,
- previous experience in the field of drug regulation for at least 5 years,
- people management skills,
- awareness in the field of pharmaceutical regulation of the EAEU and Russia
- fluent English
Образование: высшее
Условия работы:
- salary depends on experience and is discussed individually,
- convenient location of the office in the center of Moscow,
- medical insurance after 3 months,
- life insurance,
- compensation for travel expenses and meals,
- additional vacation days.