Job Description
- 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 new/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.
