Senior Manager Regulatory Affairs - Systems & Software

Senior Regulatory Affairs Manager

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.

This is an exciting opportunity to help shape the future of pathology within a market-leading organization with a strong pipeline of innovative instruments, software, and digital solutions. As a Senior Regulatory Affairs Manager, you will be a strategic regulatory partner to cross-functional teams, influencing key decisions from early development through global market access and lifecycle management. You will have the opportunity to navigate complex and evolving regulatory areasincluding integrated instrument systems, software, cybersecurity, automation, connectivity, and digital technologieswhile helping translate innovation into regulatory strategies that enable successful product development and commercialization. This role offers significant visibility, autonomy, and opportunity to influence, making it ideal for an experienced regulatory professional who enjoys solving complex problems, shaping strategy, and seeing their work directly contribute to the future of pathology and patient care.

The Opportunity

• Regulatory document and submission compilation: Oversees the development of submission/product registration dossiers of the most complex products/programs. Develops and manages comprehensive global regulatory submissions and registration plans. Mentors more junior team members in this area.
• External interface management: Leads external complex initiatives including the collaboration with key stakeholders. Cultivates and utilizes external relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Develops/maintains health authority relationships and actively shapes the regulatory environment. Has the ability to represent Roche in audits and other complex stakeholder negotiations.
• Regulatory knowledge and strategy: Lead the organization adapt to evolving regulatory environment and requirements. Experience in solving complex, critical health authority issues or equivalent understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. Ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. Proactively creates unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.
• Stakeholder management and influencing: Leads complex initiatives including collaboration with key stakeholders. Cultivates and utilizes relationships that significantly influence the current and future direction for Roche and our products. Challenges and resolves complex issues and overcomes organizational barriers. Ability to shift the perspectives of key stakeholders to achieve a specified goal. Builds common ground and alignment even if initial positions were far apart. Negotiates to maximize value for Roche and stakeholders so we have biggest impact for customers and patients.
• Decision making: Has courage to make decisions even outside of scope/comfort zone. Proactively initiates activities independently and initiates interactions across departments as applicable. Embrace the good decision making principles. Pushes decision making to the lowest appropriate level. Commits to decisions that have been made. Shows good judgment in decision making. Makes good decisions without necessarily having all the information in a timely manner.
• Innovation and problem solving: A mindset of creativity and experimentation - a true trailblazer and support radical simplification as well as continuous innovation. Challenges the organization to be curious, question the status quo and adopt new approaches. Fosters a culture that leverages unique perspectives. Has vision; often brings up ideas about potentials and possibilities for the future. Actively drives new ideas/ approaches into the business. Able to troubleshoot issues as they arise, independently develop and implement cost effective and non-complex actions solutions to ensure that daily work is completed without jeopardizing compliance. Identifies problems before they occur and actively drives mitigation strategies to avoid them. Leads others in problem-solving activities.
• VAAC Leadership and agility: Role model for we all lead. Actively develops VACC competencies and deploys them in our daily work. Fosters an inclusive environment. Shows dedication to advancement of others. Demonstrates commitment to identify, solicit and provide growth opportunities for others. Demonstrates outstanding achievement in areas of technical expertise, leading innovation and/or mobilizing the organization. Change ambassador for their environment and actively develops their agile mindsets and behaviors and encourages others to do so as well. Identifies and acts on opportunities for improvement within and across Q&R - embraces new technologies and other means to simplify and increase productivity
• Teamwork and communication: Is able to pull people together around a common goal. Seeks to understand and build on different perspectives to enhance outcomes. Addresses and resolves conflict by creating an atmosphere of openness and trust. Brings out the best in people and teams. Establishes an environment for open, honest communication for everyone and ensures that people feel that they are truly heard. Clearly articulates even the most complex concepts. Encourages direct and open discussions about important issues and can be depended on to tell the truth regardless of the circumstances. Courageously speaks the truth regardless hierarchy and creates an environment where people are appreciated and recognized for their contributions.

Who You Are

• Bachelor's / Master degree in Life Science, Data Science or related subject. Advanced degree is considered an advantage.
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
• 5-10 years experience with PhD degree, 7-10 with Masters degree and 8-10 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
• Knowledge of the European, US, China and International regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage
• Has demonstrated the ability to manage even the highest complexity of work and/or global projects.
• Preferred - You have experience with complex regulatory product launch strategies encompassing integrated systems/modular systems, change control, cybersecurity, software (SiMDs, SaMDs and AIML) for major global markets not limited to US and EU.

Locations

This role can be based in Tucson, Branchburg, Indianapolis, or Carlsbad. This is a primarily onsite role; no remote arrangements are available.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Arizona is $126,800 - $235,000. 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.

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.