Shrivathsa Achar,
Manager,
Biocon Limited
Senior management professional with over 18 years of versatile experience in leading regulatory affairs. In-depth experience in world-wide strategy and development of biosimilars, biologics, devices and API in regulated/emerging countries. A registered Pharmacist (Pharmacy graduate) . Career begun with quality assurance, manufacture, and evolved into a seasoned regulatory professional. Wide spectra of experience in small molecules, biosimilar and novel biologic API and injectable formulations. Adept in securing critical approvals, compliance with global regulations, and guiding cross-functional teams. Pivotal role in regulator/partner/client interface, quality assurance and operational excellence. Thought leader in Biosimilars, a worldwide evolving concept. Owning a Linkedin group (Biosimilars Developed and Emerging Market) of 700+ members. Actively guiding industrial peers and consultants over Biosimilar issues.
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