Executive Regulatory Affairs ( Sun pharma )
5/28/20261 min read
Roles and Responsibilities
Job Summary:
Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.
Job Description:
Evaluation of regulatory strategies for products to be registered in India
Review of CMC & other documents, coordination with cross functional teams for necessary corrections, preparation of cover letter of application & other regulatory documents, compilation of regulatory dossier and submission on the portal of regulatory authority for obtaining,
CT, BE and domestic manufacturing and marketing permission
Import & marketing approval in India
Compilation of IPC testing dossier and coordination for sample readiness and submission to laboratory
Post approval changes
Phase IV CT applications
Additional site notification/approval
BE permission for export registration
permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13
permission to import drugs for examination, test or analysis in Form-11/Form CT-17
permission to import drugs in Form 8.
Checking artworks of product label and coordinate for necessary corrections
Job Requirements
Educational Qualification
Graduate : M.Pharm
Experience
Tenure : 3 years of relevant experience
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