Job Description
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.
