Jennifer A. Head, Ph.D.

Manager of Regulatory Affairs, Microbial Manufacturing Services (MMS)
Carlsbad, California, USA

Key roles and responsibilities

  • Provide regulatory expertise in biologics
  • Develop, implements, and maintains regulatory documentation and submissions, including site master files and drug master files
  • Partner with clients to provide regulatory strategy and support for chemistry, manufacturing, and controls (CMC) regulatory submissions for advanced therapy medicinal products and cell and gene therapy products
  • Lead preparation for and/or participates in meetings with global regulatory health authorities (e.g., FDA, EMA, Health Canada)
  • Support and coordinate responses to requests from the regulatory authorities

Professional highlights

  • Authoring CMC documents for product submission and lifecycle maintenance for drug master files (e.g., DMF, ASMF, and MF)
  • Investigational new drug application (IND) and new drug application (NDA) submission and life cycle maintenance activities
  • Supported Type C and Type B meetings (face-to-face and written response only)
  • Partnered with clients to provide regulatory intelligence, competitive intelligence, and benchmark research
  • Academic research background included designing and optimizing cell-based assays to identify molecules to be used in identification of potential novel targets and antiviral drugs to combat human pathogenic arenaviruses and vaccine development for Rift Valley fever virus


  • Jean B. Kempner Postdoctoral Fellow and Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant recipient
  • Doctor of Philosophy in Microbiology and Immunology from University of Texas Medical Branch (Galveston, TX)
  • Bachelor of Science degree in Medical Technology from University of Texas MD Anderson Cancer Center School of Health Professions (Houston, TX)
  • Bachelor of Science degree in Biology from Texas A&M University Corpus Christi (Corpus Christi, TX)

Scientific Expertise

  • Regulatory strategy for marketing of controlled substances, new molecular entities, and new chemical entities
  • Regulatory intelligence and interpretation of regulatory guidance
  • Developing, editing, and reviewing regulatory submissions
  • Cell and gene therapy CMC expert
  • Microbiology and immunology
  • Viral pathogenesis
  • Medical technology
  • Central nervous system and oncology pharmaceuticals

Related Sites

Additional Resources