Global Head of Regulatory Affairs, Roche Diagnostics

About the role

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.

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.
• 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.