Biocon Walk In Interview For Regulatory Affairs

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.

Biocon Walk In Interview For Regulatory Affairs