Prasad Chavanke

About Prasad Chavanke

As the International Regulatory Lead for the Oncology Therapeutic Area at Amgen, I support regulatory affairs across more than 50 global markets, including key regions such as APAC, LATAM, EMEA, and Extended Europe. My role is focused on enabling regional teams to address regulatory complexities, ensure compliance, and facilitate market access for oncology products in alignment with organizational objectives. With over fourteen years of experience in global regulatory affairs and expertise in regulatory strategy, project planning, and strategic thinking, I contribute to the preparation and submission of complex regulatory dossiers. I am committed to collaborating with cross-functional teams to achieve timely product approvals, advantageous labeling, and sustainable portfolio growth while navigating diverse international regulatory landscapes.Core ExpertiseStrategic Leadership: Global RA Strategy, Reliance & Acceleration Pathways, Project OrbisSubmission Management: Multi‑Country Submissions, CTA/MA Sequencing, eCTD, RIM/VeevaLifecycle & Compliance: Post‑Approval Changes, Labeling Strategy, Site Transfers, CMC InterfacesAgency Engagement: HA Query Management, Deficiency Letters, Meeting Package Preparation

Experience

1. International Regulatory Lead (Irl) Oncology Therapeutic Area

   Amgen

   Mar 2026 — Present

Education

• UCLA Anderson School of Management

  PGP PRO - General Management, Strategy, Operations and Leadership

• Metropolitan School of Business & Management (UK)

  International Postgraduate Diploma in Project Management (Level 7) in London

  2020

• Mumbai Educational Trust, MET League of Colleges

  Bachelor’s Degree, Pharmaceutics and Drug Design

• Savitribai Phule Pune University

  Master’s Degree, Pharmaceutics and Drug Design

• UC San Diego

  Drug Discovery, Development and Drug Commercialization (DDC) - Online Offering