3.0 - 8.0 years

3 - 5 Lacs

Bengaluru

Remote

Job Description: Assist and manage (as applicable) in the preparation of regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components. Support and delivery of submission ready packages to agreed timelines and management of information required. Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications. Prior experience in Veeva vault is preferable. Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables. Develop research skills relevant information, regulations, and guidance from different regulatory agencies. Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination. Assist in the preparation of agendas, presentations, and other supporting materials for various meetings. Contribute to the development and improvement of related business processes. Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required. Ensure the learning from own projects are shared with other colleagues/within the functions. Skills Required : Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool Good Knowledge Documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market.

Posted 2 months ago

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