Strategic Director, US Regulatory Affairs - Roche
The Position
At Roche, we strive for a healthier future by innovating and ensuring that everyone has access to the healthcare they need. As the US Strategic Director, you will work at the forefront of shaping regulatory affairs in the US, supporting both global and local strategies. You will lead projects, influence policy, and collaborate with stakeholders to accelerate access to Roche’s portfolio and regulatory science. This role will have a significant impact on both project strategy and regulatory initiatives within the US and globally.
Key Responsibilities
Portfolio and Project Strategy: Assess and implement innovative strategies for individual projects and portfolios in collaboration with project leads. Identify new approaches to regulatory analysis and engagement.
Stakeholder Collaboration: Work closely with both internal stakeholders (global functions, US affiliates) and external partners (FDA, policy groups) across all Roche’s customer areas, including diagnostics, pharma, and medical devices.
Regulatory Strategy Leadership: Support the Roche Diagnostic Policy and Strategy agenda. Guide teams through all phases of strategic planning, design, and execution.
Thought Leadership: Lead and represent Roche as an industry thought leader on regulatory and policy matters.
Clinical & Regulatory Alignment: Collaborate with Clinical Development & Medical Affairs to ensure clinical studies align with regulatory requirements early in the development process.
Impactful Strategy Execution: Develop and implement strategies to generate evidence that supports successful submissions in the US. Foster agility across regulatory functions and assess the impact of evolving regulations.
Business Results & Leadership: Drive business results, aligning with Q&R Strategy and ensuring team efforts reflect the priorities of Roche’s portfolio. Provide senior leadership by mentoring teams and supporting their professional growth.
Who You Are
Education: Bachelor’s or advanced degree in science or a related field with a deep understanding of the diagnostics industry.
Experience: Minimum 10 years of experience, with specific expertise at the US FDA in diagnostics or medical devices.
Regulatory Knowledge: Experience with IVD, pharmaceutical, and/or medical device industries. Strong knowledge of regulatory compliance, cGMPs, QSRs, ISO13485, and 27001.
Leadership & Collaboration: Proven track record of leading cross-functional teams and building strong relationships within matrix organizations. Experienced in motivating and coaching teams to ensure customer-focused strategies.
Strategic Skills: Strong strategic thinking, planning, and organizational skills, with the ability to manage complex regulatory challenges.
Influencing Skills: Excellent communication, negotiation, and conflict management abilities to drive alignment across all levels of the organization.
Locations
Preferred locations: Indianapolis, or Washington DC.
Remote work arrangements considered under exceptional circumstances.
Relocation assistance available.
Salary Range
The expected salary for this position based on the location of Indianapolis ranges from $144,600 to $314,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other factors. A discretionary annual bonus may be available based on individual and company performance.
Benefits
Roche offers a comprehensive benefits package, details of which can be found on our website.
About Roche
Roche is a global leader in healthcare, with over 100,000 employees working towards a shared goal: advancing science and ensuring healthcare access for generations to come. Our products and services have impacted millions, from diagnostics to treatments, ensuring better health outcomes globally. We encourage innovation and foster a collaborative culture, driving impactful changes in healthcare.
Join us in building a healthier future, together.
Equal Opportunity Employer
Roche is committed to creating a diverse and inclusive workplace. We provide equal employment opportunities without discrimination based on protected status, including veterans and individuals with disabilities.
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