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Regulatory Specialist

Pfizer


Location:
Minsk
Date:
01/25/2018
2018-01-252018-02-25
Pfizer
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Job Details

Organization of the process of registration, renewals (confirmation of registration), registration of the variations (updates) of Pfizer medical products in Belarus.







**Main responsibilities:**







Development of regulatory strategies to support the registration of new products, line extensions, major variations and lifecycle management



Facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization



Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders



Timely submission and approval of new registrations, renewals, variations of Marketing Authorizations of medicinal products



Preparation the product labeling and linguistic check in conformity with the legal and company requirements



Artworks preparation and approval



Proper maintenance of internal regulatory databases



Liaising with the regulatory authorities







**Skills and Qualification:**



University degree in Pharmacy, Medicine, Biology, Chemistry (preferred)



Experience on a similar position at least 2 years



Previous experience in the pharmaceutical field preferred



Deep knowledge in pharmaceutical legislations - national and EU regulations



Ability to work under pressure within strict timelines



Proficiency in English



Excellent communication skills



Computer literacy







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
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