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International Regulatory Affairs Manager

Posted: 6 days ago

Job Description

International Regulatory Affairs ManagerLocation: RussiaIndustry: PharmaceuticalEmployment Type: Full-timeAbout the RoleWe are seeking an experienced International Regulatory Affairs Manager to oversee and manage product registration and regulatory compliance activities in Russia and international markets. The ideal candidate will have deep knowledge of Russian pharmaceutical regulations, hands-on local registration experience, and strong connections with regulatory authorities and government agencies.Key ResponsibilitiesLead and coordinate regulatory submissions and product registration processes in Russia and other assigned international markets.Maintain up-to-date knowledge of local and international regulatory requirements, guidelines, and policies.Establish and maintain effective communication with Russian health authorities and other relevant government bodies.Prepare, review, and submit documentation for new product approvals, renewals, and variations.Collaborate closely with R&D, Quality, and Commercial teams to ensure compliance across the product lifecycle.Provide regulatory strategy and support for new product launches and market expansion initiatives.QualificationsBachelor’s degree or above in Pharmacy, Life Sciences, or related field.Minimum 3–5 years of experience in pharmaceutical regulatory affairs, with proven local registration experience in Russia.Fluent in English and Russian.Strong understanding of Russian regulatory systems and procedures.Established relationships with local regulatory authorities or government agencies preferred.Excellent communication, negotiation, and problem-solving skills.

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