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27.01.2021

Regulatory Affairs Specialist

Dr. Reddy's Laboratories
Фармацевтика

    International pharmaceutical company Dr. Reddy's Laboratories announces vacancy of Regulatory Affairs Specialist.

     

    Responsibilities

    • Preparation of registration dossiers, their renewal and variations to registration in order to ensure timely regulatory submission.
    • Pre- and post- registration artwork, PIL, AND, state inspection documentation and communication of relevant registration documents, queries from MoH with corporate office; along with relevant support to GMP and QC team at Ukraine.
    • Review of draft regulatory documents on their correctness.
    • Communicate and follow-up with RA service agencies and vendors in order to receive samples and standards for registration purposes.
    • Receive samples and standards for registration purposes.
    • RA support operations in order to ensure optimum and smooth regulatory functioning.

     

    Requirements

    • Higher education preferably in medicine, pharmacy, chemistry.
    • Work experience from 3 years on the preparation of registration documents, technical work related to the preparation of registration materials, interaction with the company's head office in support of the registration process.
    • ability to quickly and correctly make decisions in difficult situations related to production and import, stress resistance, teamwork skills.
    • Basic knowledge of Pharma industry, Pharma registration process, Ukrainian regulatory requirements.
    • English - upper-intermediate level; Russian and Ukraine - fluent.

     

    Company offers the following compensation & benefits

    • Work in friendly environment with professional team.
    • Professional development opportunities.
    • Competitive compensation and benefits package
    • Working hours: Mn-Fr, 8.30-17.30.

     

    Please provide your application in English.