Biocon Limited is HIRING!
We are looking for dynamic individuals seeking to elevate their careers in the pharmaceutical industry!
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:
•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.
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