Global Head of Regulatory Affairs, Roche Diagnostics

Roche • Pleasanton, CA

8d • $346,640 - $454,965 • Hybrid

About The Position

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single 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. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

We are looking for a strong visionary and a scientifically credible leader ready to facilitate product registrations of our rich pipeline of products for the benefit of the patients across the world. As the Global Head of Regulatory Affairs, you enable and empower your team to deliver on our vision through embedding new ways of working and demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviors. You will be a member of the Global Quality, Regulatory and External Affairs leadership team and represent the global function on the Roche Diagnostics Solutions Leadership Team (RDSLT). You will build a high performing team in the area of global regulatory registrations enabling global access to our diagnostic solution for customers and patients. You will partner primarily with the Roche Diagnostics Solutions Head and the Customer Area Heads of the RDSLT to support them in the delivery of their respective strategies and solutions. You will identify the registration strategies to enable global access to our diagnostics solutions. You will play a key role in implementing relevant aspects of the Diagnostics Strategy and contribute to the overall Roche Diagnostics Vision.

Requirements

• 15+ years of progressively responsible Regulatory management experience preferably in both International and US arena
• Experience in Dia or MedTech or both
• Previous demonstrated success in the Regulatory arena and IVD field
• 5-7 years leading and managing teams and developing/managing a budget
• Progressive Regulatory management experience in IVD, featuring a proven track record of filings (510ks, PMAs, IDEs, global dossiers, and registrations), direct negotiations with the US FDA and global regulators, and active leadership within the broader regulatory community (e.g., CDRH, RAPs, MDIC, AdvaMed).
• University degree level qualification in a relevant field (a relevant post-graduate qualification e.g. MSc; MBA; or higher degree is preferred)
• Strong leadership experience, preferably with extensive experience of building and leading diverse, global teams, and/or matrix leadership of enterprise-level technology-based projects in relevant areas.
• Good balance between technical expertise and organizational leadership, visionary and collaboration.
• Demonstrated passion for and role-modeling of VACC (visionary, architect, coach and catalyst) leadership, with proven ability to lead with a creative mindset, very high self-awareness and for acting as a coach and mentor for other leaders.
• Passion for people development and effective mentoring while promoting a culture of trust and support.
• Previous experience in managing areas relevant to Diagnostics Solutions, or business similar experience; coupled with a proven track record of delivery.
• Highly developed leadership and people influencing skills in a matrixed environment, seeking to understand different perspectives and needs, gain broad partner buy-in, and co-create.
• Proven experience in leading collaborative technological innovation and continuous improvement efforts that have yielded tangible results and/or positive impact for patients or business stakeholders.
• Ability to build and sustain strong collaborative relationships and networks with partners across a complex global organisation such as the Roche Diagnostics. Able to foster positive partnerships through effective influencing, negotiation and conflict management skills. Ability to integrate your work in the context of wider strategic frameworks (e.g. other business unit strategies; enterprise-wide strategies, etc) and in a fast-moving and agile environment.
• A strong and influential communicator, able to establish external partnerships with relevant partner organizations and stakeholders in the wider arena, and/or to act as an ambassador for Roche.
• Ability to work independently and influence without authority. Highly developed competencies in thinking strategically, analytically and innovatively. Able to quickly and creatively analyze situations and provide solutions to complex challenges.
• A critical thinker who is able to analyze possibilities and solutions and make pragmatic trade-offs.

Responsibilities

• Provides strategic direction for Global Regulatory Submissions with leadership of teams in Europe, US and APAC.
• Acts as a point of regulatory contact with the US FDA, international regulatory agencies and other regulatory bodies as well as Affiliates.
• Works closely with all Roche Diagnostics affiliates to ensure timely availability of registration data and dossiers to enable rapid patient access to our product portfolio.
• Monitors the global regulatory environments, and provides management with assessments of the impact of new and changing regulations within the Customer Areas.
• Drives the development of best in class Regulatory processes, practices and submissions strategies leading to successful diagnostic solutions registrations.
• Demonstrated experience of working in a matrixed organization, ability to build strong relationships and effective stakeholder management.
• Responsible for effective resource management across the teams, in alignment with the respective Lifecycle teams.
• Drive process standardization and reuse where it makes sense (common assets, technical standards) balancing creativity and innovation.
• Foster an agile mindset and ways of working with a focus on delivering high quality submissions.
• Build and provide effective leadership for the RA team in a manner that is consistent with the Roche Values, leadership commitments and Diagnostics Cultural Dimensions.
• Seek to inspire and lead the team to deliver ground-breaking solutions that will ensure that Diagnostics Solutions products are recognized as being the best in the Diagnostics industry and maintains our #1 position in the future.

Benefits

• Relocation benefits are available for this role.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive