Global Head of Regulatory Affairs, Roche Diagnostics

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.

Your main responsibilities will include:

• 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.

In this role you will own:

• Product registration strategy supporting the overall Diagnostics Solutions strategy and the individual Lifecycle Team Product strategy
• RA resource allocation and performance management
• QMS modules for registration (including IT systems)
• On time delivery of the product registration to the lifecycle teams and the commercial affiliates
• Growth of technical capabilities in the RA team
• Knowledge & Expertise Management within the RA team

Who You Are

We are looking for a passionate and decisive business leader. You demonstrate energy, passion, courage, vision and the drive to be at the forefront of innovative technological changes in a competitive environment, for the benefit of patients, our people, and the business.

Moreover you bring:

• 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.

Experience, Skills, Knowledge:

• 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.

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.