Gerard Neeraj Anto
Senior Manager, Regulatory Affairs CMC @ Amgen India
About
Regulatory Affairs professional with international work experience in the Biopharmaceutical industry. Detail oriented with proven ability to execute high quality regulatory submissions, achieve regulatory approvals, and formulate effective regulatory strategies for success.
India
Greater Hyderabad Area
Pharmaceuticals
Product Launch, New Product Introduction, Cross-functional Coordination, Good Manufacturing Practice (GMP), cGMP manufacturing, Regulatory Labeling, Post Approval Change Management, Lifecycle Management, Variations, Regulatory Filings, Regulatory Documentation, EMA, Chemistry, Manufacturing, and Controls (CMC), Bill of Materials, Document Management, SAP Materials Management (SAP MM), Aseptic Processing, Media Fills, Oracle Agile PLM, TrackWise
Experience
Senior Manager, Regulatory Affairs CMC
Amgen India
Hyderabad
Associate Manager, Global Regulatory Affairs
Biocon Biologics
Bengaluru, Karnataka, India
Regulatory Affairs Manager - CMC Science & Strategy
Amgen
Thousand Oaks, California, United States
Senior Associate, Manufacturing - New Product Introductions
Amgen
Thousand Oaks, California, United States
Senior Associate, Regulatory Affairs - Site CMC
Amgen
Thousand Oaks, California, United States
Global Quality Business Analyst
BioMarin Pharmaceutical Inc.
Novato, California, United States
Business Process Excellence Intern
BioMarin Pharmaceutical Inc.
Novato, California, United States
Graduate Student Consultant
Boehringer Ingelheim
Regulatory Affairs Intern
Amyris
Emeryville, CA
Graduate Student Consultant
Thermo Fisher Scientific
Education
Keck Graduate Institute
Regulatory Affairs, Bioprocessing, Biotech Management
SRM IST Chennai
Biotechnology
Gerard Neeraj Anto's Contact Information
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