Looking to build a career in Regulatory Affairs (RA) within the pharmaceutical industry? Kilitch Drugs India is hiring for the position of Regulatory Affairs Officer / Trainee Officer in Navi Mumbai, Maharashtra. This is an excellent opportunity for B.Pharm and M.Pharm graduates with 0–2 years of experience to gain hands-on exposure in dossier preparation, FDA coordination, and international regulatory submissions.
With growing demand for Regulatory Affairs jobs in India, especially in ROW (Rest of World) markets, this role offers practical experience in CTD/ACTD dossiers, licensing, and compliance processes.
Job Overview
- Company: Kilitch Drugs India
- Position: Regulatory Affairs Officer / Trainee Officer
- Location: Navi Mumbai (Panvel), Maharashtra
- Experience: 0–2 Years
- Qualification: B.Pharm / M.Pharm
- Salary: ₹12,000 – ₹20,000 per month
- Job Type: Full-Time
Key Responsibilities
Regulatory Affairs Officer:
- Preparation and compilation of CTD/ACTD dossiers for ROW markets
- Coordination with internal departments for regulatory documentation
- Review of key documents:
- DMF (Drug Master File)
- Analytical reports
- Specifications
- Process validation protocols & reports
- BMR, COA, PDR, stability data
- Handling health authority queries related to dossier submissions
Trainee Officer – Regulatory Affairs:
- Assist in preparation of CTD/ACTD dossiers
- Coordinate with QA and marketing teams for:
- Licensing documentation
- FSC (Free Sale Certificate)
- COPP (Certificate of Pharmaceutical Product)
- Support in FDA-related applications and queries
- Participate in FDA office visits for licensing work
Eligibility Criteria
- Educational Qualification: B.Pharm / M.Pharm
- Experience:
- Officer: 1–2 years preferred
- Trainee: Freshers can apply
- Basic knowledge of:
- FDA regulations
- COPP, FSC applications
- Dossier preparation
Salary & Benefits
- Salary Range: ₹12,000 – ₹20,000 per month
- Benefits Include:
- Paid Time Off
- Paid Sick Leave
- Provident Fund
Work Location
- Panvel, Navi Mumbai, Maharashtra
- Candidates must be able to commute or relocate before joining
How to Apply
Interested candidates can send their updated resume to:
Make sure your resume highlights your experience in Regulatory Affairs, dossier preparation, and FDA documentation to improve your chances of selection.