Executive – Regulatory Affairs Jobs at Sun Pharma
The Executive – Regulatory Affairs role at Sun Pharmaceutical Industries Ltd offers an exciting opportunity for regulatory professionals to work in R&D Regulatory Affairs and contribute to global submissions and lifecycle management across MENA markets. This Executive Job position supports regulatory compliance, quality dossier preparation, and timely product approvals in a leading pharmaceutical organization. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Executive – Regulatory Affairs
- Location: Baroda
About the Company
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress, ‘Take charge’ with confidence, and ‘Thrive together’ through collaboration and shared success.
Educational Requirements for an Executive Job
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M. Pharm
Key Responsibilities for an Executive Job
- Regulatory submission of new products, renewals, variations, response to queries and life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals.
- Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
- Reviewing documents (Development report, scale-up report, specification, stability protocol), artworks, etc., before initiation of Exhibit batches for adequacy is required for this Executive Job role.
- Review & prepare response to deficiency, enabling approval of products filed to the regulatory agency.
- Prepare and review variations as per the country-specific requirements to support approval of changes such as API vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products, etc.
- Prepare, review and circulate the approval package with the product history sheet to stakeholders upon receipt of approval and update the same based on queries and variations.
- Ensure reposition of comprehensive product information into the central repository.
- Review regulatory filing impact of variations, change controls, etc.
Skills Required for an Executive Job
- Strong understanding of regulatory submissions and lifecycle management
- Knowledge of CMC documentation and regulatory compliance
- Ability to review dossiers, variations, and regulatory responses
- Coordination and communication with internal stakeholders
Why This Job Role?
This Executive Job role offers hands-on exposure to global regulatory markets, including South Africa, the Middle East, and GCC, along with opportunities for continuous professional growth, collaboration, and meaningful impact within a leading pharmaceutical company. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
