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Sun Pharmaceutical Industries Ltd
Sun Pharma is hiring experienced professionals for India Regulatory Affairs at its R&D Regulatory Affairs division. This opportunity is suitable for M.Pharm graduates with 8–10 years of experience in regulatory submissions, CMC documentation, and domestic drug registration.
Job Overview
| Details | Information |
|---|---|
| Company Name | Sun Pharma |
| Job Title | Manager II – India Regulatory and Business Continuity |
| Department | R&D – Regulatory Affairs |
| Job Grade | G11A |
| Job Location | Vadodara, Gujarat |
| Qualification | M.Pharm |
| Experience | 8–10 Years |
| Job Type | Full-Time (not specified in the supplied listing) |
| Travel Requirement | Not Applicable |
Key Responsibilities
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Evaluate regulatory strategies for products intended for registration in India.
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Coordinate with cross-functional teams to obtain documents required for regulatory submissions.
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Review Chemistry, Manufacturing and Controls (CMC) documents in accordance with applicable regulatory guidelines.
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Review specifications for bulk drugs and pharmaceutical formulations to ensure regulatory compliance.
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Review clinical trial and bioequivalence study documents for inclusion in regulatory applications.
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Conduct literature searches to support regulatory application strategies.
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Prepare safety and efficacy rationales for new drugs and fixed-dose combinations (FDCs) using published literature.
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Prepare executive summaries for Subject Expert Committee (SEC) referrals for drugs not approved in India.
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Collect finalized CMC, clinical trial and bioequivalence documents and compile dossiers for regulatory submissions.
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Submit New Drug (ND), Subsequent New Drug (SND) and FDC applications through the SUGAM portal for manufacturing, marketing and clinical trial permissions, as applicable.
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Review draft product specimens, labels and cartons.
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Prepare prescribing information with reference to international prescribing information.
Educational Qualification
– Required qualification: Master of Pharmacy (M.Pharm).
Experience Required
Candidates should have 8–10 years of relevant professional experience, preferably in India Regulatory Affairs, with expertise in regulatory dossier preparation, CMC review, drug registration and regulatory submissions.
Why Join Sun Pharma?
Sun Pharma offers an environment focused on professional development, collaboration and continuous improvement. This opportunity allows experienced regulatory professionals to contribute to pharmaceutical product registrations and regulatory compliance in India.
How to Apply
Interested candidates should visit the official Sun Pharma careers portal and search for the relevant India Regulatory Affairs vacancy.
Official Careers Website: Sun Pharma Careers
Note: The supplied description mentions both “Senior Executive – India Regulatory Affairs” and “Manager II – India Regulatory and Business Continuity.” Verify the exact designation and current vacancy status on the official careers portal before applying.
To apply for this job please visit careers.sunpharma.com.
