Cipla is hiring for the position of Team Member โ RA Medical Writer in Mumbai. This is an excellent opportunity for professionals with experience in Regulatory Affairs Medical Writing, dossier preparation, SmPC, PIL, and Module 2 documentation for ROW markets.
Candidates with 2โ7 years of experience in regulatory medical writing and pharmaceutical documentation can apply for this Mumbai-based opportunity.
Job Overview
| Particulars | Details |
|---|---|
| Company | Cipla |
| Job Role | Team Member โ RA Medical Writer |
| Experience Required | 2 โ 7 Years |
| Job Location | Mumbai |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Medical Writing |
| Industry | Pharmaceuticals |
| Salary Estimate | โน8 โ โน16 LPA (Expected) |
| Application Mode | Online |
Key Responsibilities
The selected candidate will be responsible for preparing and reviewing regulatory medical writing documents for product registrations across ROW (Rest of World) markets including SSA, LATAM, Middle East, APAC, CIS, North Africa, and Central America.
Regulatory Medical Writing Responsibilities
- Prepare regulatory medical writing (RMW) documents for dossier submissions
- Draft and review:
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflet (PIL)
- Package Insert (PI)
- Expert Reports (ER)
- Therapeutic Information Forms (TIF)
- Prepare Module 2 documents:
- 2.4 Non-clinical Overview
- 2.5 Clinical Overview
- 2.6 Non-clinical Summary
- 2.7 Clinical Summary
- Develop scientific and regulatory justifications including:
- Biowaiver justification
- Pack size justification
- Hardness justification
- Medical rationale for indications and posology
- Support regulatory strategy for emerging and non-regulated markets
Cross-Functional Coordination
The RA Medical Writer will collaborate with multiple teams including:
- Regulatory Affairs
- Pharmacovigilance
- Clinical Operations
- Packaging Teams
- Bioequivalence Teams
- Project Management Teams
The role also involves coordination with external vendors and support for MSA/SOW tracking and renewals.
Eligibility Criteria
Educational Qualification
Candidates from the following backgrounds may apply:
- B.Pharm
- M.Pharm
- Pharm.D
- Life Sciences
- Related pharmaceutical disciplines
Experience Required
- 2 to 7 years of experience in:
- Regulatory Affairs Medical Writing
- Dossier preparation
- SmPC/PIL authoring
- ROW market submissions
- CTD/ACTD documentation
Preferred Skills
Key Skills for RA Medical Writer Jobs
- Regulatory medical writing
- SmPC preparation
- PIL and Package Insert drafting
- Module 2 documentation
- Regulatory submissions
- Biowaiver documentation
- Clinical overview writing
- Dossier compilation
- Pharmaceutical regulatory affairs
- Scientific writing
Why Join Cipla?
Working with Cipla offers exposure to global regulatory markets and cross-functional pharmaceutical operations.
Employee Benefits
- Opportunity to work on international regulatory submissions
- Exposure to ROW markets and global compliance standards
- Career growth in Regulatory Affairs and Medical Writing
- Collaborative pharmaceutical work environment
- Learning opportunities in dossier management and labeling documentation
How to Apply
