Sun Pharma Hiring IRA Executive

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : 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
End Date : 30th March 2026