Raptim Research Pvt. Ltd. has announced a new opening for Regulatory Affairs – DCGI professionals at its Mahape, Navi Mumbai operation. This opportunity is suitable for M.Pharm candidates with 1–4 years of relevant regulatory affairs experience and hands-on knowledge of the SUGAM portal.

The selected professional will support DCGI regulatory submissions, clinical trial applications, BENOC, Test License, import licensing, CTRI submissions, and NDPS-related regulatory activities. Candidates looking for Regulatory Affairs jobs in Navi Mumbai and having experience with Indian pharmaceutical regulatory requirements can consider this opportunity.

Raptim Research Regulatory Affairs Job Overview

Key Responsibilities

Candidates selected for the Regulatory Affairs DCGI job at Raptim Research will be responsible for:

• Preparing and reviewing DCGI applications for BENOC, Test License, Working Standard Import License, and Clinical Trial Applications.
• Preparing responses to regulatory queries related to BENOC, Test License, Working Standard, and clinical trial applications.
• Reviewing and submitting information to the Clinical Trials Registry – India (CTRI).
• Handling quota allocation and import applications related to narcotic drugs and psychotropic substances.
• Preparing and submitting responses to regulatory queries concerning NDPS substances.
• Managing quarterly returns for NDPS substances to the Central Bureau of Narcotics (CBN) and State FDA.
• Supporting NDPS-2 and NDPS-6 licensing requirements with the State FDA.
• Ensuring accurate regulatory documentation and timely submissions to applicable regulatory authorities.

Qualification and Experience

Candidates applying for this Raptim Research Regulatory Affairs vacancy should meet the following requirements:

Educational Qualification:
M.Pharm in Pharmaceutics or Pharmaceutical Sciences.

Experience:
Candidates should have 1–4 years of relevant experience in pharmaceutical regulatory affairs or closely related DCGI regulatory activities.

Essential Skill:
Applicants should be well versed with the SUGAM portal and understand regulatory submission processes.

Candidates with practical exposure to DCGI applications, CDSCO/SUGAM submissions, CTRI, BENOC, Test Licenses, Clinical Trial Applications, State FDA requirements, and NDPS regulatory documentation will be particularly relevant for this position.

Why Consider This Opportunity?

This Regulatory Affairs opening provides an opportunity to gain or strengthen practical exposure across several important areas of Indian pharmaceutical regulation. The role involves direct work with DCGI submissions, clinical trial regulatory documentation, SUGAM portal activities, CTRI submissions, import licensing, and NDPS compliance.

For regulatory affairs professionals seeking broader hands-on exposure to Indian regulatory processes, the position can provide valuable experience across multiple submission and compliance activities.

How to Apply

Interested and eligible candidates should send their updated resume to:

Email: rakesh.talwatkar@raptimresearch.com

Email Subject: Resume for Regulatory Affair – DCGI