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Senior Executive – India Regulatory Affairs

Sun Pharma
Sun Pharma
8-10 years
Not Disclosed
Vadodara, India
1 May 8, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Senior Executive – India Regulatory Affairs Job in Vadodara | Sun Pharma

Company: Sun Pharmaceutical Industries Ltd.
Job Title: Senior Executive – India Regulatory Affairs / Manager II – India Regulatory & Business Continuity
Department: R&D Regulatory Affairs
Location: Vadodara (Baroda), Gujarat, India
Job Type: Full-Time
Industry: Pharmaceutical / Regulatory Affairs / Clinical Research


About Sun Pharma

Sun Pharmaceutical Industries Ltd. is one of the world’s leading specialty generic pharmaceutical companies, delivering innovative and high-quality healthcare solutions across global markets. The company has strong expertise in pharmaceutical research, regulatory sciences, clinical development, and product commercialization.

Sun Pharma offers a collaborative work culture focused on innovation, professional development, regulatory excellence, and global healthcare advancement.


Job Overview

Sun Pharma is hiring a Senior Executive – India Regulatory Affairs for its R&D Regulatory Affairs division in Vadodara. The selected candidate will be responsible for managing regulatory strategy, dossier compilation, regulatory submissions, CMC document review, clinical and bioequivalence documentation review, and coordination with cross-functional teams for product approvals in India.

The role requires strong expertise in Indian regulatory requirements, SUGAM portal submissions, dossier preparation, clinical trial documentation, and regulatory strategy for pharmaceutical products including ND, SND, and FDC applications.

This opportunity is ideal for experienced Regulatory Affairs professionals with strong exposure to CDSCO regulations and pharmaceutical dossier management.


Experience Required

Experience Level

  • Mid-Level to Senior-Level Regulatory Affairs Professional
  • Freshers are not eligible

Required Experience

  • Minimum 8–10 years of experience in:
    • Regulatory Affairs
    • Pharmaceutical Regulatory Submissions
    • Dossier Compilation
    • Indian Regulatory Compliance

Preferred Industry Experience

  • Pharmaceutical Industry
  • Generic Drug Development
  • Clinical Research & Regulatory Operations

Educational Qualification

Required Qualification

  • Master of Pharmacy (M.Pharm)