Kamla Lifesciences Ltd. is inviting applications for the position of Regulatory Affairs Officer for its Injectable division located in Boisar, Tarapur. This is an excellent opportunity for experienced pharma professionals looking to build a strong career in global regulatory affairs, eCTD submissions, injectable dossier preparation, and international market compliance.
Candidates with experience in USFDA, EU, TGA, and ROW market submissions are encouraged to apply. Professionals with injectable regulatory affairs exposure and strong CTD/eCTD documentation skills can take advantage of this growing opportunity in the pharmaceutical regulatory sector.
Job Overview
| Particulars | Details |
|---|---|
| Company Name | Kamla Lifesciences Ltd. |
| Job Role | Regulatory Affairs Officer |
| Department | Regulatory Affairs |
| Experience Required | 2-6 Years |
| Qualification | B.Pharm / M.Pharm / Life Sciences |
| Job Location | Boisar, Tarapur, Maharashtra |
| Industry | Pharmaceutical / Injectable Manufacturing |
| Employment Type | Full Time |
Key Responsibilities
The selected candidate will be responsible for:
- Preparation, review, and submission of CTD/eCTD dossiers for global markets
- Handling product registrations, variations, renewals, and lifecycle management
- Responding to regulatory authority queries and deficiency letters
- Ensuring compliance with USFDA, EU, TGA, ROW, and other international regulatory guidelines
- Coordinating with QA, QC, manufacturing, and cross-functional departments for timely submissions
- Maintaining regulatory documentation and submission timelines
- Supporting injectable product regulatory compliance activities
Required Qualifications
Candidates applying for this Regulatory Affairs Officer job should meet the following criteria:
- B.Pharm, M.Pharm, or Life Sciences qualification
- 2-6 years of Regulatory Affairs experience in injectable pharmaceutical companies
- Strong knowledge of CTD/eCTD submissions
- Exposure to international regulatory markets including USFDA, EU, TGA, and ROW
- Excellent communication, analytical, and documentation skills
- Experience in injectable dossier handling is mandatory
Preferred Skills
- Regulatory submission management
- Injectable product lifecycle management
- Global pharma compliance knowledge
- Technical documentation expertise
- Deficiency response preparation
- Regulatory strategy coordination
Why Join Kamla Lifesciences?
- Opportunity to work on global regulatory submissions
- Exposure to international pharmaceutical markets
- Growth-oriented and collaborative work culture
- Career advancement in injectable regulatory affairs
- Work with an expanding injectable manufacturing organization
Salary & Benefits
Kamla Lifesciences is expected to offer an attractive salary package based on candidate experience and expertise.
Estimated Salary Range: ₹4.2 LPA – ₹8.5 LPA
Additional benefits may include:
- Performance-based growth opportunities
- Professional learning environment
- Exposure to regulated markets
- Long-term career development
How to Apply
Interested and eligible candidates can send their updated resume to:
Email: anjali.yadav@kamlagroup.co.in
Contact Numbers: 8956480712 / 7972964497
Applicants should mention “Regulatory Affairs Officer – Injectable” in the email subject line for faster processing.
Job Location
Boisar, Tarapur, Maharashtra, India
