Regulatory Affairs Manager

About the role

At Roche Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team handles regulatory projects and overarching regulatory topics with a specific focus on Companion Diagnostics. You will work in an open-minded environment, collaborating closely with colleagues across departments and countries.

You will oversee regulatory document and submission compilation, including developing submission and product registration dossiers for complex products or programs. You will manage parts of comprehensive global regulatory submissions and registration plans while interfacing with external management. Your role involves understanding external stakeholders' needs, building enduring relationships, and applying effective stakeholder management practices.

You will contribute to audits by supporting preparation, execution, and follow-up, and lead the organization in adapting to evolving regulatory environments. You will interpret regulators' thinking to navigate complex situations, create innovative regulatory strategies, and influence decision-making to accelerate worldwide approvals. Partnering with stakeholders, you will proactively address challenges and drive solutions that shape Roche's future direction.

You will model VAAC Leadership and agility, act with integrity, and foster an inclusive environment. Your ability to unite teams around common goals, resolve conflicts, and bring out the best in people will be key to success.

Responsibilities

• Oversee regulatory document and submission compilation, including developing dossiers for complex products/programs.
• Develop and manage parts of comprehensive global regulatory submissions and registration plans.
• Interface with external management and stakeholders, communicating needs effectively.
• Build enduring external relationships and apply stakeholder management practices.
• Support preparation, execution, and follow-up for audits.
• Lead organizational adaptation to evolving regulatory environments and requirements.
• Interpret regulators' thinking to navigate complex situations and influence strategies.
• Create unique and innovative regulatory strategies to avoid obstacles and accelerate approvals.
• Partner with internal and external stakeholders to provide optimal solutions.
• Take initiative to address problems or opportunities and involve collaborators for best outcomes.
• Develop relationships that influence Roche's current and future direction.
• Demonstrate courage in decision-making, even outside your comfort zone.
• Model VAAC Leadership and agility, identifying opportunities to develop VACC competency.
• Act with integrity, passion, and honor commitments while contributing to an inclusive environment.
• Unite teams around common goals and build on diverse perspectives to enhance outcomes.
• Address and resolve conflicts by fostering openness and trust.

Requirements

• Bachelor’s or Master’s degree in Life Science, Data Science, or a related field (or equivalent experience). Advanced degree preferred.
• 3-5 years of experience with a PhD, 5-7 years with a Master’s degree, or 6-8 years with a Bachelor’s degree in IVDs, Medical Devices, Pharma, or Biopharmaceuticals, with significant experience in Regulatory Affairs.
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
• Knowledge of European, US, China, and other international regulations, with the ability to interpret and implement quality standards.
• Ability to manage complex work and parts of global projects.

Preferred Qualifications

• Experience in Companion Diagnostics.
• Experience with systems and software.

Locations

This position is local to Tucson, Arizona; Indianapolis, Indiana; or Branchburg, New Jersey. No relocation benefits are available.

Pay

The expected salary range for this position based on the primary location of Arizona is $106,100 to $197,000. 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.

Benefits

This position qualifies for the benefits detailed at the provided link.

About Roche

A healthier future drives us to innovate. Together, over 100,000 employees across the globe are dedicated to advancing science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in over 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 to deliver life-changing healthcare solutions that make a global impact.