Openings for Regulatory affairs professionals in Biocon


Biocon Biologics

About Biocon

Biocon, an internationally reputed pharmaceutical and biological manufacturing body that established its journey in 1993. This company serves the purposes in the areas of medicinal chemistry, in vivo pharmacology, biology, toxicology, Process R&D, cGMP manufacturing, analytical development and custom synthesis
The firm has accreditations like iso 9001:2008. It has also animal facilities authorized by Indian authorities. This serves for 331 clients globally including start-up companies. Large pharma/biotech, chemical, animal health and nutritional companies from 25 years.
The company focuses on client satisfaction areas of safety, quality, integrity and ethics. Recently it made an agreement with GSK in the area of advanced drug delivery system. Received PMDA accreditation, expanded collaboration with Syngene, Baxter till 2024. This has been awarded with CMO Leadership awards by life science leader magazine in Newyork. 

About the Job 

Designation: Senior Exe /Assistant Manager/ Deputy Manager
Experience Req.: 4 yrs. - 10 yrs.

 Hands on experience on preparation, review and submission of ANDA/ANDS in US/Canada market, including Module 1.
* Experience and knowledge on life cycle management for the products filed in US/Canada.
* Review of technical (developmental and plant) documentations required for dossier submission.
* Comprehensive and up-to-date knowledge on regulatory guidelines/requirements.
* Providing necessary regulatory inputs to different cross functional teams during different stages of product development and manufacturing.

Candidate with relevant exp. can share profiles on [email protected]