Micro Labs is hiring Regulatory Affairs Executives / Sr. Executives in Chennai. This is an excellent opportunity for B.Pharm/M.Pharm professionals with 2+ years experience in CTD/eCTD dossier preparation and regulatory submissions. Candidates with exposure to global regulatory markets (US, EU, ROW) are highly preferred.
If you are looking to build a career in Regulatory Affairs jobs in India, this opening offers strong growth in pharmaceutical compliance, dossier management, and global submissions.
Job Overview
- Role: Regulatory Affairs Executive / Sr. Executive
- Company: Micro Labs
- Location: Chennai
- Experience: 2โ5 Years
- Qualification: B.Pharm / M.Pharm
- Openings: 4
- Employment Type: Full-time
Key Responsibilities
- Prepare and manage CTD/eCTD dossiers for regulatory submissions
- Handle documentation for ANDA, DMF, and global submissions
- Ensure compliance with ICH guidelines and GMP requirements
- Coordinate with cross-functional teams for submission timelines
- Review and compile regulatory documents for US, EU, and ROW markets
- Maintain regulatory databases and submission records
Required Qualifications
- B.Pharm or M.Pharm with minimum 2+ years of experience
- Strong understanding of CTD/eCTD dossier structure
- Knowledge of global regulatory guidelines (USFDA, EMA, ROW)
- Proficiency in MS Office tools
- Excellent analytical, documentation, and communication skills
Preferred Skills
- Hands-on experience with eCTD publishing software/tools
- Exposure to ANDA/DMF submissions
- Familiarity with ICH guidelines and GMP compliance
Salary & Benefits
- Estimated Salary: โน4.5 LPA โ โน8 LPA (based on experience)
- Career growth in Regulatory Affairs domain
- Exposure to global pharmaceutical markets
- Opportunity to work on high-impact regulatory submissions
Why This Role Matters
Regulatory Affairs professionals play a critical role in ensuring that pharmaceutical products meet global compliance standards. This job strengthens expertise in drug approval processes, dossier preparation, and regulatory strategy, making it highly valuable for long-term career growth.
How to Apply
