Role & responsibilities

a.Manage end-to-end regulatory projects related to drugs and
healthcare products.
b.Coordinate preparation, review, and submission of regulatory
documents.
c.Track application status on CDSCO portals and maintain project
trackers.
d.Ensure timely completion of assigned regulatory activities.
e.Handle regulatory activities related to:
CDSCO Drug Import License
Manufacturing License Coordination
Recent Drug Approval Support
Regulatory Submissions and Compliance Requirements
Other pharmaceutical regulatory approvals
f.Review client-provided documents and prepare regulatory checklists.

g.Identify documentation gaps and coordinate with clients for required
information, communicate project status and timelines.
h.Maintain proper records of regulatory documents and project files.
i.Coordinate with Regulatory Affairs, Documentation, Legal, and
Business Development teams.
j.Stay updated with CDSCO notifications, regulatory changes, and
compliance requirements.

📌 Drug Regulatory Affairs Officer New Delhi
🏢 ELT Corporate
📍 New Delhi