PDRO Global Team Leader - Regulatory Information Management (RegIM)

South San Francisco, California
United States

Job ID: 3426317815

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The Position

The Regulatory Information Management Group (RegIM) is responsible to manage the regulatory data globally. Working closely with regulatory and cross-functional colleagues, the RegIM group ensures global data are available in a timely manner and are compliant as per regulation and/or internal pre-defined criteria. The team further submits data to health authorities directly or indirectly via local affiliates.

As global team leader in the Regulatory Information Management Group, you will provide direction and leadership to RegIM and manage a sub-team across global sites in order to maximize their capability and contribution in providing high-quality deliverables. You will be a member of the Regulatory Operations (PDRO) extended leadership team and actively contribute in annual and longer-term vision, mission, strategy, goals, objectives and infrastructure of global PDRO.

Tasks / Responsibilities

  • Advocates/drives changes within the organization and supports management and staff in a matrix environment, utilizing their broad knowledge base.
  • Ensures delivery and consistent execution of regulatory information management according to regulations and/or internal requirements.
  • Stay abreast of internal and external developments, trends and other dynamics relevant to the information management and its compliance management; ensures team awareness and training regarding law, regulations and guidelines governing the development, license management and marketing of drugs and biologics
  • Leads and/or contributes to the development of global standards, processes and initiatives by providing technical and functional expertise.
  • Leads recruitment, hiring and on-boarding for direct reports in the group; drives performance management, talent management for the assigned sub-team.

Who You Are

Qualifications / Skills

  • Life Sciences or Business/IT degree or relevant regulatory affairs experience
  • Proven experience (>5 or more years) in drug development and regulatory affairs incl. expertise of international regulations, processes and previous people management experience
  • Demonstrate leadership skills (evidence of constructive initiative, ability to handle sensitive communication challenges, demonstrated commitment to quality by example).
  • Demonstrate responsiveness and ability to effect issue resolution through influence management
  • Excellent communication skills; strong influencing and negotiation skills

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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