Our client - international clinical, regulatory and pharmacovigilance solution provider is looking for a Regulatory Affairs Specialist experienced with Russia and EAEU (medical devices) for remote work

Responsibilities:

·       Responsible for Russia and EAEU RA operations

·       Manage and facilitate all registration related activities

·       Compile, coordinate and monitor applications for registration, renewals, variations in accordance to the national and EUEA legislation, standard operating procedures

·       Make regulatory monitoring of the current duties related with particular product

·       Maintain contact with regulatory authorities client/sponsor representative

·       Provide the Regulatory team with regulatory input in order to obtain timely regulatory approvals for the products

·       Translate/update the specific product dossier documents

·       Update and collect information on registration instructions and regulations

Requirements:

·       University degree in Medicine, Pharmacy, Life Sciences

·       RA experience for MD is a must

·       Highly experienced in local Regulatory Affairs operations for the medicinal products as well as support for the other functions such as Pharmacovigilance and Quality Assurance, experience with review of local marketing materials

·       Fluency in Russian and English

Company offers:

·       Competitive salary (fix and annual bonus)

·       Medical insurance

·       Work within global team with international company

·       Remote work (no office in Moscow)