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Regulatory Affairs Consultant- Ukraine - Oferta z Jobs.pl

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Regulatory Affairs Consultant- Ukraine

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  • Regulatory Affairs Consultant- 3-6 Month Contract-Home based/Remote Ukraine Level: Regulatory Affairs Consultant- Ukraine Contract: 3-6 months Type of contract: Part time Location: Ukraine (remote working/homebased) Summary We are looking for a Regulatory Affairs Consultant to manage local regulatory affairs activities for Ukraine. The successful candidate will be responsible for providing local regulatory information and advice as well as preparing local submissions for Ukraine. Please see the details below; Responsibilities * Planning, reviewing and coordination of post approval submissions * Experience authoring/reviewing module 1 (administrative documents and all required legal documents) * Experience with post-approval activities such as variations, renewals, label changes, licence applications and change of licence applications * Strong local Regulatory Affairs experience for Ukraine * Ability to develop and contribute regulatory strategy * Responsible for product local Regulatory information and advice for Ukraine * Able to interact with and respond to agency enquiries * Ensure regulatory processes are in line with internal and global policies (SOP's) * Keep up to date with local and international regulatory legislation * Responsible for updating Label changes and responsible for distribution of up to date versions of SmPC's * Able to liaise with external vendorsEducation * Degree in relevant qualification e.g. Master in Pharmacy, Chemistry, Biology, Biochemistry * 2 years' experience minimum * Strong local regulatory affairs knowledge for Ukraine * Excellent written and verbal communication * Able to manage multiple projects at a time * Strong IT skills e.g. MS office etc…This is a 3 Months contract with a strong possibility of an extension. Please make an application or contact: Amie Touray (0)#LI-AT1


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