Chapter Lead Medical Value Assays in Penzberg bei Roche

Who We Are

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.

Role Purpose

As the Medical Value Assays Chapter Lead, you will be a member of the Diagnostics Solutions Regulatory Affairs Leadership Team (RLT). This role is equivalent to a Director/Sr Director Regulatory Affairs. In this position, you will be a leading figure and key point of contact for Roche Diagnostics’ regulatory capabilities in Medical Value Assays. You will improve the chapter’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 Chapter members specialized in In Vitro Diagnostic, including their skills in technical regulatory knowledge, strategic thinking, verbal and written communication and cross-functional leadership. As a people leader of Chapter members, you will be responsible for designing and optimizing Chapter 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 Chapter.

In your work with the Chapter you will:

• Empower staff and delegate decision making to those closest to the work

• Enable individual contributors to proactively seek advice to develop the most creative and innovative global registration and submission strategies

• Advocate inclusion of innovative approaches within projects that help advance our policy objectives

• Encourage ongoing knowledge sharing of regulatory and project intelligence

• Self direct career development

• Radically simplify, and focusing on the most impactful work to advance the customer needs

• Standardize processes, leveraging systems and tools and valuing data as an asset

• Partner primarily with the Leads within Regulatory Affairs for the different Customer Areas. These interactions are intended to support bringing the right capabilities and expertise to the efforts and squads to deliver across Customer Area priorities (who organize around business value).

• Play a key role in crafting and implementing key aspects of Regulatory Affairs’ mid- to long-term strategy and ultimately contribute to the overall Roche Diagnostics Vision.

You will be responsible to:

• Develop and coach Regulatory Affairs staff to enable the greatest impact for our customers

• Assist in growth of technical regulatory capabilities

• Maintain knowledge and expertise management

• Coach and empower staff to deliver best in class Regulatory processes, practices and submissions strategies leading to successful diagnostic solutions registrations with leadership of teams in Europe and US.

• Act as subject matter expert with the US FDA, international regulatory agencies and other regulatory bodies to advance project and policy objectives

• Monitor the global regulatory environments, and provide staff and stakeholders with assessments of the impact of new and changing regulations.

• 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 Regulatory Affairs 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.

You will ensure that Roche Diagnostics’ capabilities in Medical Value Assays thrive by:

• Leveraging a consolidated view of the Chapter’s capabilities to represent the most senior level of specialized regulatory expertise in Medical Value Assays towards Business and other Functions

• Defining the short and long term capability needs for the Chapter to deliver on the Function and Network strategies, and