Walk in Drive in Regulatory Affairs Department at Biocon- 5th May 2024

Biocon Biologics Limited

Website Biocon

About Biocon

Biocon is an Indian biotechnology company that focuses on research, development, and manufacturing of pharmaceuticals, primarily in the areas of diabetes, cancer, and autoimmune diseases. Founded in 1978 by Kiran Mazumdar-Shaw, Biocon has grown into one of the leading biotech companies in Asia. It is known for its innovative approaches to drug development, including the use of biologics and biosimilars. Biocon has a strong presence in both the domestic and international markets, with a commitment to delivering affordable healthcare solutions.


Regulatory Affairs


3-12 years


M.Pharma / M.Sc / B.Pharma

Job Location:



Formulation Regulatory Affairs – US/Canada Market: Pre-Approval
Managing pre-approval activities for products intended for the US/Canada market, including deficiency management and change control assessment.

Formulation Regulatory Affairs – US/Europe Market: Post-Approval
Handling post-approval activities for products in the US/Europe market, such as submission of supplements/variations, PADER/PSURs, annual reports, deficiency responses, and life cycle management.

Formulation Regulatory Affairs: Emerging Markets
Expertise in registration processes for various emerging markets, addressing queries, and managing post-approval life cycle.

API Regulatory Affairs: DMF Filing/Submission
Managing Drug Master File (DMF) submissions globally, handling customer queries, post-approval changes, and providing regulatory insights.

Key Skills

  • Proficiency in US/Canada Market regulations, with expertise in deficiency management.
  • Timely preparation and submission of supplements/variations, PADER/PSURs, annual reports, and handling post-approval deficiency responses.
  • Registration experience in diverse emerging markets, adept at life cycle management post-approval.
  • Expertise in DMF submission globally, addressing customer queries, managing post-approval changes, and offering regulatory guidance.

Job Location:


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.

To apply for this job please visit biocon.com%20.