Teva Pharmaceuticals Hiring In Regulatory Affairs

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.

Application Link