Job Title: Regulatory Affairs Executive / Senior Executive
Department: Regulatory Affairs
Experience: 2–5 Years
Qualification: B.Pharm / M.Pharm
Industry: Pharmaceutical – Sterile Formulations (Parenteral / Injectable / Biological Products)
Job Summary
We are looking for a Regulatory Affairs professional with 2–5 years of experience in the pharmaceutical industry. The ideal candidate should have experience in regulatory submissions for Parenteral, Injectable, and Biological products, handling RoW and CDSCO markets, and managing various online regulatory portals to ensure timely approvals and regulatory compliance.
Key Responsibilities
- Prepare, review, compile, and submit regulatory dossiers for RoW markets and CDSCO.
- Handle new product registrations, renewals, variations, amendments, and post-approval lifecycle activities.
- Prepare and review CTD/eCTD dossiers and responses to regulatory authority queries.
- Coordinate with R&D, QA, QC, Production, Packaging Development, and other cross-functional teams for regulatory documentation.
- Ensure compliance with CDSCO, ICH, WHO, and country-specific regulatory requirements.
- Maintain regulatory submission trackers, product registration databases, and document repositories.
- Review product labels, artworks, package inserts, and promotional materials for regulatory compliance.
- Support change control assessments and regulatory impact evaluations.
- Monitor regulatory timelines and ensure timely submissions and approvals.
Online Regulatory Portal Management
- Handle online applications and submissions through regulatory portals, including:
- ONDLS (Online National Drugs Licensing System)
- NSWS (National Single Window System)
- TNSWP (Tamil Nadu Single Window Portal)
- CDSCO SUGAM Portal / CDSCO Online Portal
- Upload, track, and monitor applications, approvals, licenses, and renewals.
- Coordinate with regulatory authorities for online queries, clarifications, and application status updates.
- Maintain digital records of submissions and regulatory approvals.
Required Skills
- Strong knowledge of CDSCO regulations and RoW registration requirements.
- Experience in handling Parenteral, Injectable, and Biological products.
- Hands-on experience in CTD/eCTD dossier compilation and lifecycle management.
- Experience in handling ONDLS, NSWS, TNSWP, and CDSCO Online/SUGAM portals.
- Knowledge of ICH, WHO, and global regulatory guidelines.
- Excellent documentation, communication, and coordination skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Educational Qualification
Experience
- 2–5 years of experience in the Regulatory Affairs department of a pharmaceutical company.
Product Exposure
- Parenteral Products
- Injectable Products
- Biological Products
Market Exposure
- CDSCO (India)
- RoW (Rest of World) Markets
Preferred Candidate Profile
- Experience in handling online regulatory applications and licensing processes.
- Ability to coordinate with regulatory authorities and internal stakeholders for timely approvals.
- Strong organizational skills with the ability to manage multiple regulatory projects simultaneously.
- Knowledge of regulatory lifecycle management, change control, and post-approval submissions.
Pay: ₹21,000.00 - ₹30,000.00 per month
Benefits:
Work Location: In person
