Manager
Cadila Pharmaceuticals Ltd
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Applied
Posted: 17 Dec 25
Job Description
- Compilation, review and submission of eCTD dossiers, renewal applications, variations, site transfer projects, post marketing applications and any other relevant submissions for UK/EU/AU/NZ/CA regions.
- Preparation of deficiencies responses for applications in the ICH region.
- Timely initiation and discussion with cross functional teams for necessary document required for preparation and submission of new/query response etc.
- Collaborative discussions with clients for ongoing regulatory submissions.
- Review and approve technical documents from cross functions related to registrations/submissions/variations - documents like spec/STPs, protocols/reports, MMD-I, labelling/art work etc., as required.
- Initiation of change controls and review of change controls/deviations for ongoing projects as required.
- Review and approval of SAP orders, MMD-II and MDM.
- Tracking and maintenance of the regulatory database and project trackers including defined action points and target timelines.
- Attend required technical meetings with cross-functional teams for any submission/variation related needs, as and when required.
- Arrangement of samples/impurities/working standard/reference standard and dispatch to client as required.
- Track regulatory guidelines, regulatory forums and agency website on regular intervals.
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2809358
Job Category Sales and Marketing
Locality Address
State
Country India
About Company
Cadila Pharmaceuticals Ltd
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