Raptim Research Pvt. Ltd. has an opening for Regulatory Affairs – DCGI at its Mahape, Navi Mumbai location. The position is aimed at M.Pharm professionals with 1–4 years of relevant experience in pharmaceutical regulatory affairs.
This role would suit candidates who already have practical exposure to Indian regulatory submissions, DCGI/ CDSCO processes, the SUGAM portal, clinical trial applications, CTRI, import licensing, and NDPS-related compliance.
For professionals looking to strengthen their career in Indian Regulatory Affairs, the position offers exposure to several regulatory activities rather than being limited to a single type of submission.
Raptim Research Regulatory Affairs Job Details
| Particular | Details |
|---|---|
| Company | Raptim Research Pvt. Ltd. |
| Position | Regulatory Affairs – DCGI |
| Department | Regulatory Affairs |
| Location | Mahape, Navi Mumbai, Maharashtra |
| Qualification | M.Pharm – Pharmaceutics / Pharmaceutical Sciences |
| Experience | 1–4 Years |
| Key Skill | SUGAM Portal |
| Industry | Pharmaceutical / Clinical Research |
| Application Mode |
About the Regulatory Affairs Role
Regulatory Affairs professionals play an important role in helping pharmaceutical and clinical research organizations meet the requirements of regulatory authorities.
At Raptim Research, the selected candidate will work on regulatory activities connected with DCGI submissions and Indian pharmaceutical regulations. The role includes preparing applications, responding to regulatory queries, maintaining submission-related documentation, and coordinating requirements involving different regulatory authorities.
Candidates with hands-on experience rather than only academic knowledge of the SUGAM portal and Indian regulatory processes may find this opportunity particularly relevant.
Key Responsibilities
The selected candidate will be involved in activities such as:
- Preparing and reviewing applications for DCGI-related regulatory submissions.
- Working on BENOC, Test License, Working Standard Import License, and Clinical Trial Applications.
- Preparing responses to regulatory queries and ensuring the required information is submitted accurately.
- Reviewing and submitting information to the Clinical Trials Registry – India (CTRI).
- Supporting quota allocation and import applications involving narcotic drugs and psychotropic substances.
- Preparing responses to regulatory queries related to NDPS substances.
- Managing quarterly NDPS-related returns submitted to the Central Bureau of Narcotics (CBN) and State FDA.
- Supporting NDPS-2 and NDPS-6 licensing activities with the State FDA.
- Maintaining regulatory documentation and ensuring submissions are completed within the required timelines.
- Coordinating information required for different regulatory applications and follow-ups.
Educational Qualification
Candidates should have:
M.Pharm in Pharmaceutics or Pharmaceutical Sciences
The qualification is particularly relevant for professionals who want to build their career around pharmaceutical regulatory submissions and compliance.
Experience Required
The advertised experience range is:
1–4 years
Relevant experience in Regulatory Affairs, DCGI submissions, CDSCO processes, clinical trial regulatory activities, or related Indian regulatory work would be useful for this position.
Important Skill: SUGAM Portal
Practical knowledge of the SUGAM portal is an important requirement for this opening.
Candidates should ideally understand how regulatory submissions and related activities are handled through the portal and should be comfortable working with submission documents, regulatory queries, and follow-up requirements.
Experience with the following areas can also be relevant:
- DCGI applications
- CDSCO regulatory submissions
- SUGAM portal
- CTRI submissions
- Clinical Trial Applications
- BENOC
- Test Licenses
- Working Standard Import Licenses
- State FDA requirements
- NDPS regulatory documentation
Why Consider This Raptim Research Opportunity?
One of the attractive aspects of this role is the range of regulatory activities involved.
Instead of focusing on only one submission type, the selected professional can gain exposure to areas such as clinical trial applications, DCGI submissions, import licensing, CTRI, State FDA requirements, and NDPS compliance.
For someone already working in Regulatory Affairs and looking to broaden their understanding of the Indian regulatory environment, this type of experience can be valuable for long-term career development.
Who Can Apply?
This opening may be suitable for candidates who:
- Hold an M.Pharm in Pharmaceutics or Pharmaceutical Sciences.
- Have 1–4 years of relevant Regulatory Affairs experience.
- Have hands-on knowledge of the SUGAM portal.
- Understand Indian pharmaceutical regulatory requirements.
- Have experience with DCGI/CDSCO submissions.
- Are familiar with regulatory documentation and query responses.
- Can manage multiple submissions and regulatory timelines carefully.
How to Apply for Raptim Research Jobs 2026
Interested and eligible candidates should send their updated resume by email.
Email: rakesh.talwatkar@raptimresearch.com
Email Subject: Resume for Regulatory Affair – DCGI
Candidates should make sure their CV clearly mentions relevant experience in SUGAM, DCGI/CDSCO submissions, CTRI, clinical trials, State FDA, import licensing, or NDPS regulatory activities, wherever applicable.
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Frequently Asked Questions
1. What position is Raptim Research hiring for?
Raptim Research is hiring for Regulatory Affairs – DCGI.
2. Where is the Raptim Research job located?
The position is based at Mahape, Navi Mumbai, Maharashtra.
3. What qualification is required?
Candidates should have an M.Pharm in Pharmaceutics or Pharmaceutical Sciences.
4. How much experience is required?
The advertised experience requirement is 1–4 years in relevant Regulatory Affairs or related regulatory activities.
5. Is SUGAM portal experience required?
Yes. The job information specifically highlights being well versed with the SUGAM portal as an important skill.
6. What regulatory areas are covered in this role?
The role includes activities related to DCGI applications, BENOC, Test Licenses, Working Standard Import Licenses, Clinical Trial Applications, CTRI, NDPS requirements, State FDA and related regulatory documentation.
7. Is this a Regulatory Affairs job for freshers?
The advertised requirement is 1–4 years of experience, so the opportunity is primarily intended for experienced Regulatory Affairs professionals rather than freshers.
8. How can I apply for the Raptim Research Regulatory Affairs position?
Eligible candidates can send their updated CV to rakesh.talwatkar@raptimresearch.com with the subject line “Resume for Regulatory Affair – DCGI.”