US Strategic Director - Regulatory Affairs

Roche • Washington, DC

283d • $144,600 - $314,000 • Hybrid

About The Position

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.

Requirements

• Bachelor or Advanced degree in science or a related field with a general understanding of the Diagnostics industry, lifecycle & development process and global trends.
• 10+ years of experience, including experience working at the US FDA in the areas of Diagnostics and Medical Devices.
• Knowledge in IVD, Pharmaceutical, and/or Medical Device industry; Regulatory Compliance, Federal cGMP's and QSR's, ISO13485 and 27001.
• Experience of working as/with cross functional expert(s) on projects.
• Strong strategic thinking, communication, planning and organizational skills.
• Ability to foster positive partnerships through effective influencing, negotiation and conflict management skills.

Nice To Haves

• Experience working in a matrixed organization.
• Senior-level experience leading, motivating, coaching, and developing teams.

Responsibilities

• 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, including strategy efforts through all phases of strategic planning, design, and execution.
• Act as industry thought leader in a range of focus areas and pursue the appropriate levels of performance and differentiation needed within Q&R to properly support the business.
• 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.
• Drive prioritized strategies and deliverables to have the greatest impact for our customers, including developing and implementing strategies leading to efficient evidence generation to support successful submissions in the US.
• Foster an agile mindset and ways of working across the regulatory functions.
• Assess the impact of new and changing regulations within the areas of focus.
• Inspire and lead teams to deliver ground-breaking solutions that will ensure that Diagnostics Solutions products are recognized as being the best in the Diagnostics industry.
• Drive business results and customer value by providing insights that help advance the Roche portfolio and policy priorities.
• Empower and enable project teams while serving as a Senior Advisor and Coach, providing guidance and mentorship for teams including professional development.

Benefits

• Relocation Assistance available.
• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree