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Looking to build your career in regulatory affairs with exposure to the US pharmaceutical market? Centaur Labs is currently hiring for the position of Officer in its regulatory team. This opportunity is ideal for candidates with 2–3 years of experience in CMC documentation, ANDA submissions, and FDA compliance who want to grow in a dynamic and compliance-driven environment.
Job Details
Position
Officer – Regulatory Affairs
Experience
2 to 3 years (US Market exposure required)
Qualification
- M.Pharm
- B.Pharm
- M.Sc
Job Location
India (Exact location not specified)
Roles & Responsibilities
- Author and compile CMC documentation for ANDA filings and post-approval submissions
- Coordinate with cross-functional stakeholders to collect required documents within timelines
- Review documents as per US FDA guidelines to ensure regulatory compliance
- Maintain updated knowledge of evolving regulatory requirements
- Work on eCTD software for submission and lifecycle management
- Ensure accuracy, completeness, and compliance of all regulatory submissions
Required Skills
- Strong understanding of ANDA filings and CMC documentation
- Knowledge of US FDA regulatory guidelines
- Hands-on experience with eCTD publishing tools
- Good communication and coordination skills
- Attention to detail and compliance-oriented mindset
Salary & Benefits
- Estimated Salary: ₹3.5 LPA – ₹6.5 LPA (based on experience)
- Opportunity to work on US regulatory submissions
- Exposure to global pharmaceutical compliance standards
- Career growth in Regulatory Affairs domain
How to Apply
Interested candidates can share their updated resume at:
Make sure to mention “Application for Officer – Regulatory Affairs” in the subject line for better visibility.
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