Genentech: US Regulatory Policy

OVERVIEW: 

Regulatory Policy interprets the needs of worldwide health authorities and provides strategic information necessary to advance Genentech/Roche's development and business priorities. The regulatory policy group is committed to developing frameworks that are evidence-based, innovative, ethical, and influential in the industry. 

JOB SUMMARY: 

  • Knowledge: Understanding/familiarity with US regulations pertaining to drug, biologics, and devices; understanding of processes, procedures, and issues in drug/biologics/device development. Includes knowledge of ICH (International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, and other relevant guidelines. Understanding/familiarity with the US system of government. Understanding of processes in the US Congress, the relationship between the three branches of government and basic understanding of the legal processes underpinning regulations and regulatory frameworks as related to the Food, Drug and Cosmetics Act. Understanding and familiarity with the Prescription Drug User Fee Act Reauthorization process and contents. Familiarity with competitive activity in the field. 
  • Communication: Strong written and verbal communication skills, as well as the ability to draw on various techniques to connect and engage a range of internal and external individuals, groups, and cultures, is critical. 
  • Project Management Skills: The capability to both gain and apply knowledge of fundamental project management process. 
  • Planning Skills: The capability to gain and apply knowledge of fundamental project management processes. 
  • Strategic Business Acumen: The capability to both gain and employ knowledge of Genentech and its business, strategy, priorities, and activities as well as the ability to understand a cohesive strategy and align tactical work to that vision. 
  • Time Management: The capability to manage both one's own time and that of an initiative/project to a very high standard. 
  • Team-Building Skills: The capability to encourage and enable people to work together as a team to accomplish the project, including nurturing relationships with agency and external consultant resources. 
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