Genentech: Regulatory Program Management


Regulatory professionals provide the interpretation of global regulations within their companies to facilitate drug development that meets the needs of Health Authorities, patients, and prescribers. Regulatory professionals are responsible for the design and implementation of regulatory strategies to optimally develop, license, and market products globally. At Genentech, the Regulatory Affairs Fellow will receive individual guidance from regulatory professionals and obtain an understanding of the regulatory roles and responsibilities in the drug development process. The Fellow will learn how to apply regulations and health authority guidance in the drug development process, develop regulatory strategies in collaboration with global project teams, and interact with Health Authorities. In addition, the Regulatory Affairs Fellow may also have the opportunity to learn skills in medical writing, labeling, and regulatory submission publishing. During approximately the last 6 months of the second year of the fellowship, the fellow will have the opportunity to complete a rotation at the FDA. 


The Fellow will acquire an understanding of the early and late-stage drug development process across distinct therapeutic areas: Oncology, Immunology, Infectious Disease, Ophthalmology, and Neuroscience, through direct experience and/or exposure to:

  • Regulatory Strategy 
  • Health Authority Interactions
  • Labeling
  • Post-Marketing Activities
  • Clinical Regulatory Documentation 
  • Regulatory Intelligence 
  • Clinical Trial Conduct 
  • Companion Diagnostics 
  • Chemistry, Manufacturing, and Controls 
  • Submission Publishing and Management 


The successful candidate will be working towards or have recently (within the last two years) completed an undergraduate degree, preferably in the biological sciences. Candidates may have recently completed a graduate degree (within 2 years of graduation) or be currently enrolled in a graduate program. Candidates may be PharmD or PhD graduates, but those degrees are not required. 


  • Understand the needs of the project and proactively drive them. 
  • Adapt and respond to changes in a positive and thoughtful Manner. 
  • Be comfortable with uncertainty and support a team through challenges. 
  • Able to balance multiple priorities and organize their time effectively. 
  • Identify and solve problems and, if needed, escalate issues appropriately. 
  • Use of interpersonal skills and influence to accomplish work without formal authority.