Sun Pharmaceutical Industries Ltd, India’s largest pharmaceutical company, is hiring an Executive – Regulatory & Business Continuity for its R&D1 Regulatory Affairs division at Panoli, Gujarat. This opportunity is ideal for regulatory professionals with strong exposure to DMF submissions, global regulatory guidelines, and QMS activities.
At Sun Pharma, you are encouraged to create your own sunshine—grow continuously, take ownership of your role, and collaborate within a high-performance regulatory environment.
🔍 Job Overview
- Job Title: Executive – Regulatory & Business Continuity
- Department: R&D1 – Regulatory Affairs
- Job Grade: G12A
- Location: Panoli, Gujarat
- Experience Required: 2–5 years
- Qualification: M.Sc
- Industry: Pharmaceutical / Regulatory Affairs
🧾 Key Responsibilities
As an Executive – Regulatory Affairs, your core responsibilities will include:
- Evaluation and categorization of QMS-related activities, including Change Controls, as per US FDA, EDQM, EU, UK, TGA, Japan, Korea, Canada, China, South Africa guidelines
- Review, follow-up, and compilation of dossiers for USDMF, CEP, DCP, CP, MRP submissions
- Preparation and submission of new DMFs and DMF amendments/updates based on regulatory planning
- Handling regulatory submissions for Japan, China, TGA (Australia), Canada, and other global markets
- Compilation of raw data for registration, re-registration, and regulatory authority queries for ROW markets such as China, Korea, Taiwan, Indonesia, South Africa, etc.
This role demands precision, regulatory intelligence, and strong coordination with cross-functional teams.
🎓 Eligibility Criteria
Educational Qualification
- M.Sc (Life Sciences / Chemistry / Related Discipline)
Experience
- 2 to 5 years of relevant experience in Regulatory Affairs within the pharmaceutical industry
Key Skills
- DMF lifecycle management
- Global regulatory submissions
- Knowledge of ICH, FDA, EDQM, EMA guidelines
- Documentation, compliance, and regulatory strategy
💼 Why Join Sun Pharma?
Sun Pharma offers a professional ecosystem where regulatory professionals can thrive:
- Strong learning and career growth opportunities
- Exposure to global regulatory markets
- Collaborative and innovation-driven culture
- Stable organization with long-term career prospects
- Opportunity to contribute to high-impact regulatory filings
Your success, growth, and well-being are central to Sun Pharma’s values.
📩 How to Apply
