Looking to build a strong career in Regulatory Affairs (RA) with a global pharmaceutical leader? Sun Pharmaceutical Industries Ltd is hiring an Executive – Regulatory Affairs for its R&D division in Baroda (Vadodara).

This opportunity is ideal for candidates with 1–4 years of experience in regulatory submissions, CMC documentation, and lifecycle management, especially for MENA and global markets.

If you are aiming for Regulatory Affairs jobs in India 2026, this role provides strong exposure to global dossier preparation, deficiency handling, and regulatory strategy.

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Job Overview

• Job Title: Executive – Regulatory Affairs
• Company: Sun Pharmaceutical Industries Ltd
• Location: Baroda (Vadodara), Gujarat
• Department: R&D Regulatory Affairs
• Experience: 1–4 Years
• Qualification: M.Pharm / M.Sc
• Job Type: Full-Time

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Key Responsibilities (Regulatory Affairs Executive)

1. Regulatory Submissions & CMC Dossiers

• Prepare and review CMC (Chemistry, Manufacturing, and Controls) dossiers
• Handle new submissions, renewals, and variations
• Ensure compliance with MENA regulatory requirements

2. Documentation & Pre-submission Review

• Review:
  • Development reports
  • Scale-up reports
  • Stability protocols
  • Specifications
  • Artwork compliance
• Ensure readiness before exhibit batch initiation

3. Deficiency Response Management

• Prepare responses to regulatory queries and deficiencies
• Coordinate with cross-functional teams for approvals

4. Lifecycle Management

• Manage:
  • API vendor changes
  • Test parameter updates
  • Manufacturing site changes
• Prepare variation filings as per country-specific guidelines

5. Regulatory Compliance & Data Management

• Maintain central regulatory repository
• Review change control impacts
• Circulate approval packages with product history

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Eligibility Criteria

Educational Qualification

• M.Pharm / M.Sc (Pharmaceutical Sciences, Life Sciences)

Experience Required

• 1–4 years in:
  • Regulatory Affairs
  • CMC dossier preparation
  • Global submissions (MENA preferred)

Key Skills (High-Value Keywords)

• Regulatory submissions (eCTD/CTD)
• CMC documentation
• Lifecycle management
• Variation filing
• Deficiency response handling
• Regulatory compliance

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Salary & Benefits

• Estimated Salary: ₹4 LPA – ₹8 LPA (based on experience & role level)
• Exposure to global regulatory markets (MENA, South Africa)
• Work in R&D regulatory strategy environment
• Strong career growth in Regulatory Affairs domain

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Why Join Sun Pharma?

Sun Pharma offers a growth-driven environment under its philosophy:

• “Create your own sunshine” culture
• Continuous learning & career progression
• Collaborative and innovation-focused teams
• Opportunity to work on global filings and approvals

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How to Apply

Application Link