Executive – Regulatory Affairs Job at Sun Pharma Baroda
The Executive – Regulatory Affairs role at Sun Pharmaceutical Industries Ltd offers an excellent opportunity for pharmacy and life science graduates to work on global regulatory submissions for MENA markets. This Regulatory Affairs Job position focuses on CMC dossiers, lifecycle management, and regulatory compliance within a strong R&D environment. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Executive – Regulatory Affairs
- Location: Baroda (Tandalja – R&D)
About the Company
Sun Pharmaceutical Industries Ltd is one of India’s leading global pharmaceutical companies, committed to improving patient lives worldwide. Sun Pharma fosters a culture of continuous growth, accountability, collaboration, and leadership, encouraging employees to take charge of their careers while thriving in a supportive and inclusive work environment.
Educational Requirements for Regulatory Affairs Job Role
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M.Sc
-
M.Pharm
Key Responsibilities
- Handle regulatory submissions, renewals, variations, and lifecycle management for MENA markets
- Review and prepare CMC dossiers for new product submissions
- Review development reports, scale-up reports, specifications, stability protocols, and artworks prior to exhibit batch initiation
- Preparing and reviewing responses to regulatory deficiencies to enable product approvals is required for this Regulatory Affairs Job role
- Manage lifecycle variations including API vendor changes, test parameter changes, dosage form site changes, and product harmonization
- Prepare, review, and circulate approval packages and product history sheets to stakeholders
- Ensure accurate updating and maintenance of regulatory information in central repositories
- Review regulatory filing impact of variations and change controls
- Support regulatory compliance across GCC, UAE, Oman, Saudi Arabia, Egypt, Iran, Iraq, Bahrain, and other MENA markets
Skills Required for Regulatory Affairs Job Role
- Regulatory submissions and lifecycle management
- CMC documentation review and preparation
- Knowledge of MENA regulatory requirements
- Regulatory compliance and change control assessment
- Strong documentation and coordination skills
- Stakeholder communication and collaboration
Why This Job Role?
This Job role offers hands-on exposure to international regulatory markets, end-to-end dossier management, and lifecycle activities. It provides a strong foundation for long-term growth in regulatory affairs while working with a leading global pharmaceutical organization focused on learning, collaboration, and career development. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
