Senior Manager, Regulatory Affairs – Systems & Software

• Oversee development of submission/product registration dossiers for the most complex products/programs
• Develop and manage comprehensive global regulatory submissions and registration plans
• Mentor more junior team members
• Lead complex external initiatives and collaborate with key stakeholders
• Cultivate and maintain health authority and external stakeholder relationships
• Represent Roche in audits and complex stakeholder negotiations
• Address complex health authority issues and adapt to evolving regulatory requirements
• Create regulatory strategies to avoid obstacles and accelerate worldwide approvals
• Lead stakeholder initiatives, resolve complex issues, overcome organizational barriers, and build alignment
• Make timely decisions, initiate cross-department activities, and apply sound judgment
• Drive innovation, simplification, troubleshooting, and mitigation strategies while maintaining compliance
• Lead problem-solving activities and foster continuous improvement
• Develop VACC competencies, support others’ growth, and act as a change ambassador
• Improve productivity across Q&R through new technologies and process improvements
• Build collaboration, resolve conflict, and communicate complex concepts clearly

• Bachelor’s / Master degree in Life Science, Data Science or related subject
• 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
• Demonstrated ability to manage the highest complexity of work and/or global projects
• Preferred: 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
• Primarily onsite; no remote arrangements are available
• Willingness to work in Tucson, Branchburg, Indianapolis, or Carlsbad
• Relocation benefits are not available

Demonstrates expertise in developing and managing global regulatory submissions and registration plans for complex products, while fostering collaboration and continuous improvement within teams. Possesses strong knowledge of international regulations and the ability to navigate complex stakeholder relationships effectively.

• Regulatory Affairs
• Global Regulatory Submissions
• Complex Product Launch Strategies
• Continuous Improvement
• Stakeholder Management

• Regulatory Strategy Development
• Quality Standards Interpretation
• Project Management
• Data Analysis
• Regulatory Compliance

• Mentoring
• Problem-Solving
• Collaboration
• Communication
• Decision-Making

• IVDs
• Medical Devices
• Pharmaceuticals
• Biopharmaceuticals
• European Regulations

• Integrated Systems
• Modular Systems
• Change Control
• Cybersecurity
• Software Development