Raptim Research Pvt. Ltd. is inviting applications from experienced pharmaceutical professionals for Regulatory Affairs – Clinical and Medical Writing & Regulatory Affairs positions at its Mumbai location. This is an excellent opportunity for B.Pharm and M.Pharm (Pharmaceutics/Pharmaceutical Sciences) candidates with 1–4 years of Regulatory Affairs experience who are looking to build their career in clinical regulatory submissions and medical writing.
Candidates with hands-on experience in Clinical Regulatory Affairs, BA/BE submissions, eCTD, NeeS, Medical Writing, ICH-GCP guidelines, and regulatory documentation are encouraged to apply.
Raptim Research Recruitment 2026 – Job Details
| Particular | Details |
|---|---|
| Company | Raptim Research Pvt. Ltd. |
| Job Location | Mumbai, Maharashtra |
| Department | Regulatory Affairs |
| Positions | Regulatory Affairs – Clinical, Medical Writing & Regulatory Affairs |
| Qualification | B.Pharm / M.Pharm (Pharmaceutics / Pharmaceutical Sciences) |
| Experience | 1–4 Years |
| Employment Type | Full-Time |
Open Positions
- Regulatory Affairs – Clinical
- Medical Writing & Regulatory Affairs
Key Responsibilities
Selected candidates will be responsible for:
- Preparing Clinical and BA/BE regulatory submissions.
- Compiling and reviewing eCTD and NeeS dossiers.
- Preparing Module 5 and Module 2.7 documentation.
- Drafting and reviewing Clinical Study Reports (CSR).
- Preparing Clinical Protocols, PIS-ICF, and CRF/eCRF documentation.
- Ensuring compliance with ICH-GCP and global regulatory guidelines.
- Coordinating regulatory documentation and submission activities.
- Supporting medical writing activities for regulatory projects.
- Maintaining documentation accuracy and regulatory compliance.
Required Qualifications
Applicants should possess:
- B.Pharm or M.Pharm (Pharmaceutics / Pharmaceutical Sciences)
- 1–4 years of relevant Regulatory Affairs experience
- Strong understanding of Clinical Regulatory Affairs
- Experience in BA/BE regulatory submissions
- Knowledge of eCTD and NeeS publishing
- Good documentation and communication skills
- Familiarity with ICH-GCP guidelines
Preferred Skills
- Clinical Regulatory Submissions
- Medical Writing
- eCTD Publishing
- NeeS Dossier Preparation
- Module 5 Documentation
- Module 2.7 Summaries
- CSR Writing
- Protocol Preparation
- PIS-ICF Documentation
- CRF/eCRF
- Regulatory Compliance
- ICH-GCP
- Pharmaceutical Documentation
Salary (Expected)
Based on current industry standards for Regulatory Affairs professionals in Mumbai:
₹4.5 LPA – ₹8.0 LPA (Estimated, depending on experience, skills, and interview performance.)
Why Join Raptim Research?
- Opportunity to work on global clinical regulatory projects.
- Exposure to Clinical Regulatory Affairs and Medical Writing.
- Hands-on experience with eCTD and BA/BE submissions.
- Professional growth in a reputed clinical research organization.
- Collaborative and learning-focused work environment.
How to Apply
Eligible candidates with relevant Regulatory Affairs experience only should send their updated resume.
Email Subject: Resume for Regulatory Affair
Email: rakesh.talwatkar@raptimresearch.com