Website Sun Pharma Ltd
Post Name: Executive – IRA
Job Description:
Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.
Responsibility:
• 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,
o CT, BE and domestic manufacturing and marketing permission
o Import & marketing approval in India
o Compilation of IPC testing dossier and coordination for sample readiness and submission to laboratory
o Post approval changes
o Phase IV CT applications
o Additional site notification/approval
o BE permission for export registration
o permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13
o permission to import drugs for examination, test or analysis in Form-11/Form CT-17
o permission to import drugs in Form 8.
• Checking artworks of product label and coordinate for necessary corrections
Additional Information:
Experience : 3 years of relevant experience
Qualification : M.Pharm
Location : Tandalja – R&D Baroda
Industry Type : Pharma/ Healthcare/ Clinical research
Business Unit : Regulatory Affairs
