Apply for Regulatory Affairs Officer at Kilitch Drugs India 2026. Check salary, eligibility, responsibilities, and email application details now.
Introduction
If you are planning to start or grow your career in Regulatory Affairs, this opportunity offers practical exposure to real-world pharmaceutical processes. The Regulatory Affairs Officer at Kilitch Drugs India role is ideal for B.Pharm and M.Pharm graduates who want to work on dossier preparation, FDA coordination, and global regulatory submissions. This position provides hands-on experience in compliance and licensing, making it a strong career-building option.
Job Overview
| Job Title | Regulatory Affairs Officer / Trainee Officer |
|---|---|
| Company Name | Kilitch Drugs India |
| Location | Navi Mumbai (Panvel), Maharashtra |
| Employment Type | Full-Time |
| Department | Regulatory Affairs |
| Experience Required | 0–2 Years |
| Education | B.Pharm / M.Pharm |
| Salary | ₹12,000 – ₹20,000 per month |
Company Overview
Kilitch Drugs India is a well-known pharmaceutical company engaged in manufacturing and exporting a wide range of formulations across global markets. The company has a strong presence in regulated and semi-regulated regions and focuses on maintaining international quality standards. It offers opportunities for young professionals to gain exposure in regulatory compliance and global submission processes.
Job Location & Employment Type
This is a full-time, on-site position based in Panvel, Navi Mumbai, Maharashtra. Candidates should be ready to relocate or commute to the work location before joining.
Open Positions / Department Details
The hiring is for both Regulatory Affairs Officer and Trainee Officer roles within the Regulatory Affairs department. The department handles dossier preparation, licensing, and coordination with global health authorities.
Key Roles & Responsibilities
Regulatory Affairs Officer
- Prepare and compile CTD/ACTD dossiers for ROW markets
- Coordinate with internal departments for regulatory documentation
- Review critical documents such as:
- Drug Master File (DMF)
- Analytical reports and specifications
- Process validation reports
- Batch Manufacturing Records (BMR), Certificate of Analysis (COA), Product Development Reports (PDR), stability data
- Handle queries from regulatory authorities related to submissions
Trainee Officer – Regulatory Affairs
- Assist in preparation of CTD/ACTD dossiers
- Coordinate with QA and marketing teams for licensing documentation
- Support preparation of FSC (Free Sale Certificate) and COPP (Certificate of Pharmaceutical Product)
- Assist in FDA-related documentation and submissions
- Participate in regulatory office visits and licensing activities
Eligibility Criteria
Education
- B.Pharm or M.Pharm from a recognized institution
Experience
- Regulatory Affairs Officer: 1–2 years preferred
- Trainee Officer: Freshers can apply
Skills Required
- Basic knowledge of regulatory guidelines and FDA processes
- Understanding of dossier preparation (CTD/ACTD)
- Familiarity with COPP and FSC documentation
- Good communication and coordination skills
- Attention to detail and documentation accuracy
Salary & Benefits
- Salary: ₹12,000 – ₹20,000 per month
- Paid Time Off
- Paid Sick Leave
- Provident Fund
- Opportunity to gain hands-on experience in regulatory submissions
Selection Process
The selection process may include:
- Resume shortlisting
- Technical interview
- HR discussion
How to Apply
Interested candidates can apply via email:
Make sure your resume highlights your knowledge of Regulatory Affairs, dossier preparation, and FDA documentation to improve your chances of selection.
Important Dates
- Candidates are advised to apply as soon as possible
Why Apply for This Job?
This role is highly valuable for candidates aiming to build a career in Regulatory Affairs. It provides direct exposure to global submission processes, dossier preparation, and regulatory compliance. Working in this domain helps develop expertise required for international markets, especially in ROW countries. It also opens future opportunities in regulatory, quality assurance, and pharmaceutical compliance roles.
FAQs
1. Who can apply for this job?
B.Pharm and M.Pharm graduates with 0–2 years of experience can apply.
2. What is the salary for this position?
The salary ranges from ₹12,000 to ₹20,000 per month.
3. Are freshers eligible for this job?
Yes, freshers can apply for the Trainee Officer role.
4. Is relocation required?
Yes, candidates must be able to work in Navi Mumbai (Panvel).
5. How can I apply for this job?
You can send your resume to hr@kilitchhealthcare.com.
Conclusion
The Regulatory Affairs Officer at Kilitch Drugs India is an excellent opportunity for pharmacy graduates to gain practical experience in regulatory processes. With exposure to dossier preparation and global compliance requirements, this role can significantly strengthen your career in the pharmaceutical industry. Apply early to secure your opportunity.
Disclaimer
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