Biocon is global biopharmaceutical company changing patients' lives in over 120 countries by finding new and affordable ways to treat diabetes, cancer and autoimmune diseases. Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain.
Department : Regulatory Affairs
Experience : 3-12 years
Qualification : M.Pharma / M.Sc / B.Pharma
Job Location : Bangalore
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
• 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.
Job Location : Bangalore
Walk in Interview
Date : 5th May 2024, Sunday
Time : 9:00 am to 2:00 pm
Venue : Hotel Lemon Tree Premier, HITEC City, Madhapur, Hyderabad - 500081, Telangana
Interested candidates can email their resumes to upendra.kamma@biocon.com / rashmi.gupta@biocon.com for an interview opportunity.
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