India's DMPLOI - Jobs & Networking AppSun Pharmaceutical Industries Ltd. is inviting applications for the position of Senior Executive / Manager II – India Regulatory Affairs at its R&D Regulatory Affairs Division in Baroda, Gujarat. This is an excellent opportunity for experienced Regulatory Affairs professionals with expertise in India regulatory submissions, dossier compilation, and regulatory strategy development.
Job Details
| Particulars | Details |
|---|---|
| Company | Sun Pharmaceutical Industries Ltd. |
| Position | Senior Executive / Manager II – India Regulatory Affairs |
| Department | R&D1 Regulatory Affairs |
| Location | Baroda, Gujarat |
| Qualification | M.Pharm |
| Experience | 8–10 Years |
| Job Grade | G11A |
Key Responsibilities
- Evaluate regulatory strategies for products intended for registration in India.
- Coordinate with cross-functional teams for collection of documents required for regulatory submissions.
- Review CMC (Chemistry, Manufacturing & Controls) documents as per regulatory requirements.
- Review specifications for APIs (Bulk Drugs) and finished formulations.
- Review clinical trial and bioequivalence study documents for regulatory applications.
- Conduct literature searches and scientific assessments to support regulatory strategies.
- Prepare safety and efficacy rationales for New Drugs and Fixed Dose Combinations (FDCs).
- Develop executive summaries for Subject Expert Committee (SEC) referrals.
- Compile and review dossiers for regulatory submissions.
- Submit ND, SND, and FDC applications through the SUGAM portal for manufacturing, marketing, and clinical trial approvals.
- Review draft labels, cartons, and packaging materials.
- Prepare prescribing information based on international regulatory references.
Eligibility Criteria
Educational Qualification
- Master of Pharmacy (M.Pharm)
Experience Required
- 8–10 years of experience in Regulatory Affairs, dossier preparation, regulatory submissions, and India regulatory compliance.
Preferred Skills
- Strong understanding of Indian regulatory guidelines.
- Experience with SUGAM portal submissions.
- Knowledge of CMC documentation and dossier compilation.
- Expertise in clinical trial and bioequivalence documentation review.
- Strong scientific literature review and regulatory writing skills.
- Excellent coordination and cross-functional communication abilities.
Why Join Sun Pharma?
At Sun Pharma, employees are encouraged to grow professionally, take ownership, and collaborate effectively. The company offers a dynamic work environment, learning opportunities, and the chance to contribute to the development and approval of innovative pharmaceutical products.
Job Location
📍 Baroda, Gujarat
Experience Required
👉 8–10 Years in Regulatory Affairs (India Regulatory Submissions & Dossier Management)
Apply Now
Interested candidates can apply through the official Sun Pharma careers portal and explore this opportunity to advance their career in Regulatory Affairs.
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