Regulatory Affairs Officer

Обязанности:

• New medicines registration, renewals of limited Marketing Authorization, variations
• Drafting of Normative Documents, SmPC, PIL, Russian leaflets,
• Russian/EAEU Marketing Authorization files constitution,
• Answers on authorities questions,
• Planning of Marketing Authorizations stages, ordering of samples, references standards,
• WRA databases filing and correctness checking,
• Interaction within the department and transversally.

Требования к квалификации:

• Higher education in pharmacy, medicine or life sciences,
• Previous experience in the field of drug regulation for at least 3 years,
• Awareness in the field of pharmaceutical regulation of the EAEU and Russia,
• Upper-intermediate 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.