Alpesh Patel

Senior Vice President, Global Regulatory Affairs and Quality

Role
Senior Vice President, Regulatory Affairs & Quality at BioTissue
Location
Princeton, NJ, US
LinkedIn followers
500 followers

About Alpesh Patel

Extensive experience in strategic Regulatory/Quality for IND/CTA, NDA/BLA, Inspections, Tissue Products, Medical Devices, CMC, Advertising and Promotion, Labeling, and in all phases of the drug development process while maintaining a strong focus on business goals and objectives. Ensured compliance during Pre-and Post-launch commercialization efforts from a U.S and Global strategic marketing perspective.

Experience

  1. Senior Vice President, Regulatory Affairs & Quality

    BioTissue

    Jan 2026 — Present

Education

  • University of Phoenix

    MBA, Marketing

Skills

  • Pharmaceutical Industry
  • Sop
  • Fda
  • U.s. Food and Drug Administration (Fda)
  • Regulatory Compliance
  • Pharmacovigilance
  • Regulatory Requirements
  • Gmp
  • Ind
  • Regulatory Submissions
  • Leadership
  • Market Access
  • Development of Promotional Materials
  • CRO
  • Medical Affairs
  • Diabetes
  • Biologics
  • Biotechnology
  • Nda
  • Glp
  • Capa
  • Cmc
  • Clinical Development
  • Clinical Operations
  • 21 Cfr Part 11
  • Regulations
  • Ectd
  • Medical Writing
  • Clinical Trials
  • Good Laboratory Practice (Glp)
  • Infectious Diseases
  • Drug Development
  • Gcp
  • Biopharmaceuticals
  • Advertising
  • Vaccines
  • Pharmaceutics
  • Regulatory Affairs
  • Therapeutic Areas
  • Generic Programming

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Alpesh Patel — Senior Vice President, Regulatory Affairs & Quality at BioTissue in Princeton, NJ, US | Unifers