Department: Regulatory Affairs / Legal & Quality
Location: Vasai East
Experience: 2–5 Years
Qualification: B.Pharm / M.Pharm / Life Sciences / Chemistry / LLB
Job Summary
We are looking for a Regulatory Affairs & Compliance Specialist to manage FDA licensing, CDSCO approvals, import clearances, certifications, and statutory documentation. The candidate will coordinate with QA, Sales, Operations, and regulatory authorities to ensure smooth compliance and timely approvals.
Key Responsibilities
- Manage FDA applications, licenses, renewals, and certifications.
- Handle CDSCO approvals, NOCs, and PIMS documentation for imports.
- Coordinate with QA for COA, MOA, MSDS, technical files, and other documents.
- Review product labels, artwork, and regulatory documents.
- Manage ISO, CE, FDA, and other certification renewals.
- Maintain regulatory trackers and ensure audit readiness.
- Handle rent agreements, lease deeds, trade licenses, and statutory documents.
- Maintain proper physical and digital records of legal and regulatory documents.
- Coordinate with internal teams and external regulatory authorities for approvals and compliance.
Required Skills
- 2–5 years of experience in Regulatory Affairs / Compliance.
- Experience with CDSCO, FDA documentation, and import clearance.
- Knowledge of SUGAM / NSWS and PIMS portals.
- Understanding of ISO, CE, COA, MOA, and MSDS documentation.
- Good communication, follow-up, and documentation skills.
- Strong attention to detail and ability to manage multiple regulatory activities.
Industry Experience: Pharma, Medical Devices, Cosmetics, Nutraceuticals, or related industries preferred.
Direct Apply
Interested candidates can share their updated CV directly on the below number:
70213 50186
Pay: ₹25,000.00 - ₹30,000.00 per month
Work Location: In person
