Biocon Walk In Interview For Regulatory Affairs
Department: Regulatory Affairs
Experience : 3-12 years
Qualification : M. Pharma / M. Sc / B. Pharma
Job Location: Bangalore
Walk Interview Details
Date : 5th May 2024, Sunday
Time : 9:00 am to 2:00 pm
Venue : Hotel Lemon Tree Premier, HITEC City, Madhapur, Hyderabad-500081, Telangana
Role :
• Formulation Regulatory Affairs- US/Canada market: Pre-Approval
• Formulation Regulatory Affairs US/Europe market: Post-Approval
• Formulation Regulatory Affairs: Emerging markets
• API Regulatory Affairs: DMF filing/Submission
Key Skills :
• ANDA/ANDS Submission for US/Canada Market. Deficiency management for products filed in US/Canada market.
• Preparation and timely submission of supplements/variations and PADER/PSURS & annual reports. Submission of post approval deficiency response and life cycle management. Change control assessment.
• Registration expertise in various emerging markets, handling queries, post-approval life cycle management.
• DMF submission in global markets, customer query responses, post-approval changes, providing regulatory inputs.
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| Biocon Walk In Interview For Regulatory Affairs |
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