Subchapter Lead Companion Diagnostics

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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

• Bachelor or Advanced degree in science or a related field. 

• General understanding of the Diagnostics industry, lifecycle & development process and global trends 

• 7+ years of experience in Regulatory Affairs within the diagnostics industry or a related field, ideally with expertise in Companion Diagnostics.

• Knowledge in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP’s and QSR’s, ISO13485 and 27001. 

• Experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China)  

• Strong track record of building and nurturing capabilities such as technical regulatory knowledge, strategic thinking, verbal and written communication and stakeholder management 

• History of successful interactions with regulatory bodies.

Leadership Knowledge, Skills & Abilities

• Proven  ability to lead with creative attitude, very high self-awareness and being a coach and a mentor to other leaders and partners

• Demonstrates the ability to build networks and can inspire to work agile 

• Empathy towards the needs of Squads and other Chapters combined with skill of prioritizing resource involvement

• Demonstrated success in establishing a high performing environment with an excellent reputation attracting the best talent, developing and inspiring them

• Experience defining career progression and development capabilities for Regulatory Affairs in networked organization

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.

Benefits

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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