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Job description :
Job Description
To plan, initiate, co-ordinate and monitor regulatory schedule leading to timely submissions and approvals of new product registration, renewals and amendments
To liaise with relevant parties and authorities on license approval and sourcing strategy
To manage and respond to product regulatory questions
To initiate and coordinate license variations with relevant documents and supporting data
To plan and coordinate pack changes, proof reading and preparation of pack inserts and designs
To manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information
To work with appropriate functions to develop and implement regulatory plan to support commercial goals
To obtain relevant licenses and import and re-export permits, and maintain proper Poisons (Form E) records and Controlled Drugs register in compliance with regulatory requirements
To approve promotional and advertising material in accordance with regulations
To provide regulatory support on patent issues
To monitor and report on regulatory projects, regulatory environment and competitor regulatory activities on a monthly basis
To manage quality related matters
To provide regulatory input into Clinical R&D plans and trials
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