Live opening · Posted 11 days ago

Senior Manager

Biocon · Bengaluru, Karnataka, India (On-site)

Linkedin No

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At a glance

The key details from the original listing.

Posted 11 days ago

CompanyBiocon

LocationBengaluru, Karnataka, India (On-site)

Work modeNo

SourceLinkedin

Listed11 days ago

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About the role

Description supplied by the original job listing.

Job description
Participate in new molecules development activity and provide Regulatory input
CMC discussion & trouble shooting with CFT’s for DMF compilatio
DMF review as per Health Authority & Customer requiremen
Submission of DMF in CTD & eCTD format
Perform DMF Gap analysis and Risk mitigatio
Customer qualification support and address the prerequisite
Customer support with AP DMF, DS/DP registration, QP audit reports & review cycl
Regulatory agency query - preparing the action plan in discussion with CFT and submitting the response to H
Review the change controls (CCF) and provide DMF impact assessmen
Post approval change assessment and customer notificatio
Customer migration support (LCM) & business continuit
Maintain submission tracker for DMF filings, Amendments, Annual report
Tracking Regulatory commitments and completenes
DMF SAP clearance for suppl
Support CFT’s - APQR, CAPA, OOT/OOS, Customer audit, etc.
,

Work arrangement
No

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