South San Francisco
California, United States of America
Regulatory Documentation (PDRD) is part of the PD Regulatory organization. PDRD interprets the needs of worldwide health authorities, defining and executing the content and documentation strategy to support development and maintenance of global licenses. PDRD leads documentation deliverables across all therapeutic areas and phases of product development, from entry in to human to product divestiture. Leading a local or global team of Clinical Project Managers (CPM) or Regulatory Documentation Scientists (RDSes), the Regulatory Documentation Team Lead (RDTL) provides strategic oversight, leadership, management, coaching, and functional expertise to their direct reports, thus ensuring delivery of regulatory documents for assigned molecules, documents assigned to their direct reports, and/or other functional projects. The RDTL supports CPMs and RDSes in defining the content and documentation strategy for molecular programs, and oversees delivery of documents and filings by Regulatory Documentation Teams. This includes oversight of the documentation strategy and review of documents in support of molecular programs. Partnering with stakeholders and business leaders across functions, the RDTL is accountable for timely delivery of high-quality, compliant regulatory documents. Engage in Site Leadership activities to protect site culture and overall engagement. May also work on complex projects to support and coordinate assigned deliverables, and to guide the efforts of multiple staff members. The RDTL may represent and advocate for the department in key internal and external meetings, through various communications channels, or in other ways.
Major Responsibilities and Accountabilities:
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.
These are our stories - stories of the obstacles and opportunities that define and celebrate the unique people at Genentech.