Biocon was among the early movers in developing a portfolio of fermentation derived APIs. We were one among three players globally with approvals to supply the API to the U.S using innovative solid state fermentation technology. As one of the largest makers of statins and immunosuppressant in the world, we supply these APIs to over 60 countries. For more details kindly visit http://www.biocon.com
Biocon – Urgent Job Opportunity – Regulatory affairs – US market – OSD/solid orals”
Designation: Assistant Manager/ Deputy Manager
Role & responsibilities:
* Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.
* Experience and knowledge on life cycle management for the products filed in US/Canada market.
* 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.
* Responsible to understand the requirements related to US regulatory submissions.
* Review of technical (developmental and plant) documentations required for dossier submission.
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Experience Req.: 6 yrs. – 12 yrs.
Candidate with relevant exp. can share profiles on email@example.com / firstname.lastname@example.org