Gurgaon Executive Regulatory Affairs EM Market
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What you'll do
- Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
- Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.
- Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
- Prepare and review variations as per the country requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
- Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
- Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the same based on queries and variations.
- Ensure reposition of comprehensive product information into central repository
- Review regulatory filing impact of variations, change controls, etc.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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Job Summary |
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Regulatory submission of new products, variations, response to queries, Life cycle management for WHO & Sub Sahara Africa markets through preparation of quality dossiers enabling timely approvals. |
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Area Of Responsibility |
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Company
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