- To prepare, review and submit dossiers for Life cycle management, and other submissions as required for EU region. - Preparation, review and submission of eCTD Renewal, variations, post marketing applications and other related activities. - Timely initiation and follow-ups with cross functions for necessary document support for preparation and submission of current/Query response etc. - Discuss project based with immediate supervisor for all submission/Query-response/Variations etc. for technical inputs during preparation & e-Submission within stipulated timeframe agreed. - Regulatory review, technical support and submissions, as needed, for EU Site transfer projects. - Preparation and submission of variation applications to support post approval changes, new OLS and site transfer projects for EU markets.
- Review and approve SAP orders and technical documents from cross functions related to registrations/submissions/variations related all submission related documents like CC, Spec/STPs, Protocols/reports, MMDs, Labelling/Art works etc.), as required. - Prepare/update project trackers related to variations with defined action points and target timelines. - Maintain appropriate archival of submission related documents. - Regulatory support/inputs for contract manufacturing projects for UK, EU as directed. - To attend and represent my supervisor in required technical meetings with main Cross functions for any variation related needs, as and when required. - Take up for required technical support or additional activities as per business need on Supervisor instructions. - Discuss with Supervisor with daily/regular updates on projects, any technical concern.
📌 Senior Executive (India)
🏢 Cadila Pharmaceuticals
📍 India
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