Cognizant is hiring for the position of SME – Reg Affairs – Med Writing in Mumbai, India. The role focuses on regulatory affairs, medical writing, regulatory documentation, submission management, and process optimization for life sciences projects.
Job Details
| Details | Information |
|---|---|
| Company | Cognizant |
| Job Title | SME – Reg Affairs – Med Writing |
| Job ID | 00070603282 |
| Location | Mumbai, India |
| Work Model | Hybrid |
| Job Category | Technology & Engineering |
| Date Published | October 08, 2026 |
| Preferred Certification | Regulatory Affairs certification such as RAC or equivalent life sciences regulatory credential |
Position
SME – Reg Affairs – Med Writing
The role serves as a subject matter expert in regulatory affairs and medical writing, applying regulatory domain knowledge to develop compliant documentation and support regulatory business processes for life sciences projects.
Responsibilities
- Collaborate with regulatory and research teams to develop documentation strategies aligned with global regulatory and standards requirements.
- Develop regulatory submissions using Veeva and other approved platforms.
- Prepare medically accurate, evidence-based documents, including clinical overviews, summaries, and technical narratives.
- Interpret evolving regulatory requirements and translate them into practical documentation and process improvements.
- Translate clinical and research insights into structured regulatory product specialist documentation.
- Review regulatory business process documentation for consistency, traceability, and completeness across product lifecycles.
- Provide guidance on regulatory and standards compliance for life sciences projects.
- Maintain clear written communication in English and coordinate documentation workflows across onsite and remote stakeholders.
- Map product features, indications, and risk profiles to relevant regulatory frameworks.
- Monitor regulatory and R&D timelines and prioritize medical writing deliverables against regulatory milestones.
- Evaluate regulatory business processes and recommend improvements for data consistency, document version management, and audit readiness.
- Coordinate with regulatory domain experts to validate scientific content and present complex technical concepts clearly.
Eligibility & Qualifications
Candidates should have:
- Strong regulatory domain knowledge.
- Hands-on experience in life sciences regulatory documentation.
- Experience with regulatory affairs and R&D submissions.
- Experience with Regulatory Veeva for document workflows, metadata, and version control.
- Experience as a regulatory product specialist in structured product documentation covering indications, benefits, risks, and compliance status.
- Regulatory business analyst capabilities to interpret business requirements and develop regulatory documents and process descriptions.
- Deep understanding of regulatory and standards compliance and life sciences regulatory expectations.
- Practical involvement in regulatory business process services and regulatory affairs.
- Preferred certification in Regulatory Affairs, such as RAC, or an equivalent life sciences regulatory credential.
Required Skills
- Regulatory Affairs
- Medical Writing
- Regulatory Documentation
- Regulatory Submissions
- Veeva
- Regulatory Domain Knowledge
- Regulatory Compliance
- Regulatory Product Specialist
- Regulatory Business Analysis
- Life Sciences Regulatory Operations
- Document Workflow and Version Control
- Scientific Content Review
- English Communication
Application Details
Company: Cognizant
Position: SME – Reg Affairs – Med Writing
Job ID: 00070603282
Location: Mumbai, India
Work Model: Hybrid
Date Published: October 08, 2026
