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

Education

  • 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