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Regulatory Affairs Specialist, Biologics

Genpact

Bangalore

·

4 w

·

Full time

·

Healthcare

Minimum

₹400000 Per Year

Maximum

₹1800000 Per Year

Biocon is seeking a skilled Regulatory Affairs Specialist to support global biologics submissions and regulatory compliance. The role involves preparing, reviewing, and compiling dossiers (CTD/eCTD), managing product life-cycle submissions, and ensuring alignment with international regulatory requirements (US, EU, ROW). The ideal candidate has hands-on experience in biologics or biosimilars regulatory filings, excellent documentation skills, and strong collaboration with cross-functional teams (QA, QC, R&D, Manufacturing).

Location: Bengaluru, India
Experience: 410 years
Qualification: M.Pharm / M.Sc (Biotech / Life Sciences)