Regulatory Program Director or Associate Regulatory Program Director IBD Therapeutic Areas

South San Francisco
California, United States of America


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The Position

GENERAL POSITION SUMMARY/PURPOSE:
In this key strategic role within the I2ON (immunology, infectious disease, ophthalmology, neuroscience) Genentech Regulatory Program Management team you will interpret the needs of worldwide health authorities while providing the regulatory expertise to drive product development from early development to post-marketing. You will take the lead for assigned projects and represent PDR to cross-functional teams and groups and serve as the principal interface with health authorities, managing the strategies for and execution of these interactions.
With over 45 molecules in the development, Genentech, a member of the Roche group, has one of the richest and most diverse pipelines in the industry. The entrepreneurial spirit and inventiveness of our founders still defines our culture; a culture that encourages innovation and bold steps as vital partners to rigorous science. As you set off on the next leg of your regulatory career journey, explore Roche. Go ahead. Make a change. Make a difference.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • As the US regulatory subject matter expert, leads the US Regulatory strategy in a global Regulatory Affairs Functional Team (RAFT) for assigned development projects.
  • Plays a key role in creating innovative strategies to expedite development of our projects in rare diseases or Inflammatory Bowel Disease (IBD, Ulcerative Colitis and Crohn's Disease) therapeutic areas.
  • Develops regulatory strategies with global cross functional clinical, non-clinical and business development teams. Provides project teams with leadership regarding regulatory authority interactions.
  • Acts as primary liaison and manages a professional relationship between the FDA and Genentech for assigned projects.
  • Responsible for on time and quality regulatory submissions for INDs and BLAs/NDAs to the FDA.
  • Collaborates with the Canadian regulatory affiliate to develop and manage regulatory strategy and submissions to Health Canada for assigned projects. 
  • Briefs regulatory management
  • Mentors and coaches junior regulatory professionals.
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of Product Development and Regulatory to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects.
  • Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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