Biocon jobs "A"

Regulatory Affairs Biologics

4 - 8 YearsBengaluru/Bangalore Openings: 5

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 requirementsCompany Profile

Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .

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