Cadila Pharma

Major purpose of the Job :
 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.

Job Details

Skills Required

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