Job Title: Team Member – Regional RA
Location: Vikhroli, Maharashtra, India
Division: IPD
Department: IPD
Employment Type: Permanent
Req ID: 85666
Key Responsibilities:
- Dossier/DMF Submission:
- Achieve timely submission of dossier/DMF and deficiency responses to regulatory authorities by reviewing, collating, and compiling documents to ensure approvals for launch within stipulated time.
- Post-Approval Variations:
- Submit post-approval variations for changes that improve productivity, cost-effectiveness, and product quality by reviewing, collating, and compiling the variation application to meet delivery timelines and maintain product marketing authorization, renewals, and continuous validity of marketing authorizations.
- Product Dossier Maintenance:
- Maintain and update product dossiers as required to meet changes in Cipla’s internal systems, regulatory guidelines, and regulatory requirements.
- Database Management:
- Update the database (PRC/SAP-RA/table) associated with product dossier approvals by including registration details in the database.
- Regulatory Support:
- Provide regulatory support throughout the product lifecycle for smooth functioning.
- Dossier Availability:
- Ensure the availability and suitability of dossiers for out-licensing and in-licensing activities.
- Regulatory Authority Coordination:
- Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submissions done.
Education Qualification:
- B.Pharmacy, M.Pharm, B.Sc, or M.Sc.
Relevant Work Experience:
- Minimum of 5 years’ experience in regulatory activities within the pharma industry, preferably with experience working with the same region/authority.
Competencies/Skills:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Vikhroli, Maharashtra, India
