Helly Sheth

About Helly Sheth

I am a detail-oriented and results-driven professional with a Doctor of Pharmacy (Pharm.D.) and a Master’s in Regulatory Affairs. With a strong foundation in drug safety, regulatory compliance, and quality systems, I support both pharmaceutical and medical device companies in achieving global market access while ensuring product safety and regulatory alignment.My experience spans cross-functional collaboration to align technical documentation with EU MDR, ISO 13485, and FDA QMSR standards. I’ve contributed to 510(k) submissions, labeling compliance initiatives, and CE mark readiness. I also have hands-on experience in pharmacovigilance reporting, clinical trial documentation, and internal regulatory audits.Additionally, I’ve led the development and revision of Standard Operating Procedures (SOPs), helping improve documentation accuracy, audit readiness, and regulatory filing efficiency.Skilled in managing end-to-end regulatory and quality projects—from interpreting global requirements to implementing risk mitigation strategies and streamlined documentation. I’m passionate about bridging science and regulation to solve complex compliance challenges with clarity, collaboration, and strategic thinking.

Experience

1. Quality Assurance Associate

   Glenmark Pharmaceuticals

   Feb 2026 — Present · Allentown, PA, US

Education

• Sumandeep Vidyapeeth, Vadodara

  Doctor of Pharmacy - PharmD, Clinical, Hospital, and Managed Care Pharmacy

  2017 — 2023

• Northeastern University

  Master of Science - MS, Regulatory affairs