Subchapter Lead Companion Diagnsotics

The Position

At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As a SubChapter Lead for Companion Diagnostics, you will be a member of the companion diagnostics Regulatory Affairs Leadership team. In this position, you will be a leading figure and key point of contact for Roche Diagnostics' regulatory capabilities in CDx. You will improve the Subchapter's overarching expertise based on current and upcoming needs to deliver on network priorities (e.g. upcoming portfolio investments with new technology skills needed).

You will be responsible to excel in developing the capabilities of Subchapter members, including their skills in technical regulatory knowledge, strategic thinking, verbal and written communication. As a people leader of Subchapter members, you will be responsible for designing and optimizing Subchapter members' personal professional journey and coaching your direct reports. Furthermore, you will have the responsibility to maintain and improve all processes, data and technology associated with the Subchapter.

The Opportunity

• You develop and coach 10-15 Regulatory Affairs staff to enable the greatest impact for our customers. Oversight includes :
• Growth of technical regulatory capabilities, knowledge and expertise management
• Coaching and empowering staff to deliver best in class Regulatory processes, practices and submissions strategies leading to successful diagnostic solutions registrations
• Nurture and develop an empowered, knowledgeable, effective and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics' efforts with best-in-class expertise
• Serving as subject matter expert with the US FDA, Notified Bodies, international regulatory agencies and other regulatory bodies to advance project objectives
• Monitoring the global regulatory environments, and provide staff and stakeholders with assessments of the impact of new and changing regulations
• Effective resource management across the team, in alignment with the respective Lifecycle teams
• Driving process standardization and reuse where it makes sense (common assets, technical standards) balancing creativity and innovation
• Fostering an agile mindset and ways of working with a focus on delivering high quality submissions
• You enable the organization's New Ways of Working, which includes :
• Acting as Role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in We@RocheDiagnostics
• Modeling behaviors to support the organization's transformation to new, more Agile Ways of Working e.g. new decision making / governance practices, collaboration, translating common goals into 90 day action plans / OKR, etc

Who You Are

Leadership Knowledge, Skills & Abilities

Locations :

You can be based in Indianapolis, Tucson, Pleasanton, Santa Clara, Branchburg, or Carlsbad. This is an onsite opportunity. Relocation assistance is not available for this position. As this position is a global role, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities. The expected salary range for this position based on the primary location of Indianapolis is between $106,760 and $245,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.