US Strategic Director - Regulatory Affairs

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.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

As the United States (US) Strategic Director, your main objectives are to support the Global Regulatory Affairs organization on portfolio and project strategy, support and direct US policy work in coordination with our Regulatory Policy and Intelligence (RPI) group, and lead internally and externally on a variety of policy matters to accelerate access to the Roche product portfolio and advance regulatory science. You will be a member of the Global Regulatory Affairs Leadership Team (RLT) and report directly to the Global Head of Regulatory Affairs.

You will also, working with cross-functional partners within and outside the Global Quality and Regulatory (GQ&R) organization, assist Global Regulatory Affairs colleagues in translating US regulatory developments and developing and implementing strategies across the division to meet patient, customer and business needs. You will be a key translator for project teams and the US affiliate of US regulatory policies and requirements that impact our portfolio and business strategy.

The Opportunity

• Assess individual project and portfolio strategies, in conjunction with project leads, as well as identify and apply innovative approaches to regulatory analysis and engagement that accelerate access.

• Collaborate with internal stakeholders from multiple global functions and the US affiliate, and external stakeholders, in particular the US FDA, on a wide range of matters across all four of our customer areas, both product-specific and above product.

• Support and lead projects in the Roche Diagnostic Policy and Strategy agenda. This includes strategy efforts through all phases of strategic planning, design, and execution.

• Act as industry thought leader in a range of focus areas. Pursue the appropriate levels of performance and differentiation needed within Q&R to properly support the business. It is expected to know both the external and internal contexts for areas of focus.

• Partner with Clinical Development & Medical Affairs to strategize and educate regarding regulatory requirements and ensuring clinical studies meet submission needs early in the development process. Interact within Regulatory Affairs and cross functional partners to strategically advance specific portfolio and policy topics in the US.

• Drive prioritized strategies and deliverables to have the greatest impact for our customers. This includes:

  • Developing and implementing strategies leading to efficient evidence generation to support successful submissions in the US.

  • Fostering an agile mindset and ways of working across the regulatory functions.

  • Assessing the impact of new and changing regulations within the areas of focus.

  • Inspiring and leading teams 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.

• Drive business results and customer value. You take an enterprise wide view to provide insights that help advance the Roche portfolio and policy priorities. Define your key objectives and ensure alignment with the organization's business strategy and build on priorities that align with Q&R Strategy.

• Empower and enable project teams, while serving as a Senior Advisor and Coach, including:

  • Provide guidance and mentorship for teams including professional development.

  • Encourage teams to seek creative and innovative approaches to the development and execution of plans and deliverables.

  • Provide feedback on work-in-progress while ensuring autonomy of decision making.

  • Ensure teams proactively seek out and consider the voice of the FDA in defining their priorities and outputs

  • Advise the head of regulatory, network leads, and other regulatory staff on portfolio and project topics, where needed.

Who You Are

• You have a Bachelor or Advanced degree in science or a related field with a general understanding of the Diagnostics industry, lifecycle & development process and global trends.

• You have 10+ years of experience and must have experience working at the US FDA in the areas of Diagnostics and Medical Devices.

• You hold knowledge in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP's and QSR's, ISO13485 and 27001.

• You have experience of working as/with cross functional expert(s) on projects.

Leadership & Senior Management Skills

• You have a record of building collaborative relationships with peers and teams, helping cross-functional teams address strategic opportunities and solve problems across the organization.

• You are experienced with working in a matrixed organization, and have the ability to build strong relationships and effective stakeholder management.

• You hold Senior-level experience leading, motivating, coaching, and developing teams to drive customer focus in our mindset, work priorities and collaborative behaviors.

• You show evidence of strong strategic thinking, communication, planning and organizational skills required, e.g., through experience successfully leading strategic initiatives with a desire and openness to learning and continuous improvement.

• You are able to foster positive partnerships through effective influencing, negotiation and conflict management skills to achieve alignment up and down the organization.

Locations

You are preferably based out of Indianapolis, or Washington DC. We will consider remote work arrangements under exceptional circumstances.

Relocation Assistance is available.

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 $144,600 and $314,000. 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

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.

As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.

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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