Regulatory Affairs Biologics

Company Name: Biocon

Experience : 4-8 years

Qualification:  M.Sc. / M.tech Biotechnology / Ph.D. Life Science / Biotechnology

Job Description

• Write & review regulatory submissions like IND, IMPD, MAA, NDA, DMF and documents for regulatory advices.
• Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.
• Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables.
• Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements.

Apply 

• Send Resumes to:  ruchi.panjwani@biocon.com