Team Member – Regional Regulatory Affairs at Cipla
About Cipla:
Cipla Pharmaceuticals invites applications for the role of Team Member – Regional Regulatory Affairs. Join us in our mission of ‘Caring for Life’ and contribute to a sustainable future.
Position: Team Member – Regional RA
Organization: Cipla
Qualification: B.Pharma, M. Pharm, BSc, MSc
Experience: 5 years
Salary: ₹2.00 – ₹5.4 LPA (Approx)
Location: Maharashtra, India
Job Purpose:
- Submit product documents to regulatory authorities as per country-specific requirements.
- Ensure approvals and market launch within stipulated timeframes.
- Handle post-approval changes, document maintenance, and updates throughout the product lifecycle.
Key Responsibilities:
| Area | Tasks |
|---|---|
| Dossier Submission | Achieve timely submission of dossiers/DMFs – Respond to deficiencies to ensure product launch approvals |
| Post-Approval Variations | Submit variations for productivity, cost-effectiveness, and quality – Maintain Marketing Authorization and renewals |
| Document Maintenance | Update product dossiers per internal changes and regulatory guidelines |
| Database Management | Update PRC/SAP-RA tables with registration details post-approval |
| Regulatory Support | Provide support throughout the product lifecycle |
| Dossier Availability | Ensure dossiers are suitable for out-licensing and in-licensing |
| Regulatory Authority Interaction | Coordinate with authorities (EU, NZ & TGA) for submissions and approvals |
Competencies/Skills:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
For more details, visit the link.
