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 - Regulatory Affairs
Job Description
• To evaluate regulatory strategy for products to be registered in India.
• To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India.
• Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
• To review specification for bulk drug and formulations as per regulatory expectation.
• Responsible for reviewing clinical trial and bioequivalence study documents to be submitted in regulatory applications.
• To search literature through various websites as per the application strategy.
• To prepare rationale on safety and efficacy of new drug/FDC by referring published literature.
• To prepare executive summary for SEC referral for drugs not approved in India.
• To get all final CMC/CT/BE final documents from cross functional team and compilation of dossier for regulatory submission.
• To file ND/SND/FDC application on SUGAM portal for getting domestic manufacturing and marketing permission / clinical trial permission etc.
• To review draft specimen or label and carton.
• To prepare prescribing information by referring international prescribing information.
Additional Information
Experience : 2-4 years
Qualification : M.Pharm
Location : Baroda
Job Grade : G12A
Industry Type : Pharma/ Healthcare/ Clinical research
Business Unit : Regulatory Affairs
End Date : 20th June 2026
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