Ajay Parashar

About Ajay Parashar

Senior Oncology Regulatory Strategy Leader at Merck KGaA/EMD responsible for technical and regional leadership across Oncology and Immuno-oncology projects. 15+ years of experience across therapeutic areas including Oncology, Immuno-oncology, Pediatric Oncology, Cell Therapy, Metabolics (diabetes), Ophthalmology and Dermatology, with development of global regulatory strategy and execution including first cycle approvals for Imfinzi, Acalabrutinib, Moxetumomab, Qternmet XR, Qtern, Aczone, Lumigan and Ganfort across major regions and types of submissions (IND, CTA, NDA, BLA, MAA, etc.) across the lifecycle.

Experience

1. Senior Director, Global Oncology Regulatory Strategy

   Merck KGaA, Darmstadt, Germany

   Apr 2021 — Present · US

   Senior Regulatory Strategy Leader in US; Group Director with 7 direct reports; Global Regulatory Lead for 5 Oncology Assets. Responsible for developing the vision and leading the execution for the US Reg Onc organization and providing regional and technical leadership across all of the projects including representation at Governance Meetings as appropriate. Focus on development of People, strategic steer and delivery on Projects, assessing existing Processes and making recommendations on changes as appropriate and increasing credibility of the US Reg Onc team within the overall Organization. Regulatory Representative on Due-diligence activities for promising drug candidates for early and late stages of development.

Education

• Yale School of Management

  Executive Education (company sponsored)

• Northeastern University

  Master’s in Pharmaceutical Sciences, Specialization Novel Drug Delivery Systems, Delivery of anti-cancer compounds by Liposomes and Nanoparticles

• University of Southern California

  Master’s in Management, Specialization Drug Development

• Delhi University

  Pharmacy (foreign Pharmacy doctoral equivalent)