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Regulatory Specialist


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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.
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