Regulatory Affairs Associate I
Company: Teva Pharmaceuticals
Job ID: 55405
Location: Bangalore, India, 560064
Key Responsibilities:
- Dossier Evaluation: Assess dossier suitability for specific territories.
- Regulatory Strategy: Prepare and submit MAAs to Medis clients.
- Client Support: Engage actively and provide extensive support to Medis clients to facilitate MA approvals.
- Liaison Role: Act as the primary contact between R&D, Site RA, Clinical team, Medis clients, and other relevant functions.
- Timeline Monitoring: Coordinate and manage the flow of information internally and externally throughout the registration process until MA approval.
- Regulatory Guidance: Offer guidance and support to Medis.
- Database Maintenance: Maintain databases and other document management systems/lists.
- Special Projects: Contribute to specialized projects as directed by Medis RA managers.
- Dossier Audits: Organize dossier audits and due diligence for clients.
- Status Updates: Provide regular status updates to management.
Qualifications and Experience:
- Educational Background: B.Pharmacy, M.Pharmacy, or MSc in Chemistry.
- Regulatory Expertise: Extensive expertise in global regulatory strategies.
- Regional Knowledge: Strong skills and in-depth understanding of regulatory environments across various regions, including LATAM, Canada, China, etc.
