Venu R.

About Venu R.

I am a regulatory affairs leader with experience developing and executing US and global regulatory strategies across early- and late-stage programs. My background spans IND submissions, global health authority interactions (FDA, Health Canada, EMA), lifecycle management, and cross-functional regulatory leadership within emerging biotech environments.I have led regulatory strategy for complex biologic programs, partnering closely with clinical, CMC, medical affairs, and executive leadership to align regulatory planning with corporate objectives and key inflection points.In addition to regulatory strategy, I bring strong experience in regulatory operations and intelligence — including submission planning and execution, infrastructure development, global publishing workflows, and proactive regulatory research to inform risk mitigation and program direction.Currently, I advise biotech organizations on regulatory strategy, submission execution, and operational readiness. This work has strengthened my ability to assess programs holistically, identify regulatory risk early, and build scalable regulatory processes.I am particularly motivated by roles where regulatory strategy serves as a driver of program advancement and organizational growth.Open to connecting with teams seeking strategic regulatory leadership across US and global programs.

Experience

1. Senior Manager, Global Regulatory Affairs Strategy

   Syndax Pharmaceuticals

   Sep 2025 — Present

Education

• College of Lake County

  Associates of Arts, Science and Technology

  2015 — 2018

• University of Wisconsin-Madison

  Master of Science - MS, Applied Biotechnology - Quality Assurance and Validation

  2021 — 2024

• University of Wisconsin-Parkside

  Bachelor's degree, Biochemistry, Biology

  2018 — 2020