Senior Regulatory Strategy Lead - Systems & Software

Roche; Carlsbad (CA); On-site; USD 127,000 - 235,000; Full time

Benefits offered by this job

Bonus eligibility

Onsite role

Job summary

Roche is seeking a Senior Regulatory Affairs Manager to shape regulatory strategy for advanced diagnostics and software; lead cross-functional teams through complex, global submissions and lifecycle management. The role involves navigating integrated systems, cybersecurity, and digital technologies with global health authorities.

You will influence decisions across regions, mentor staff, and align regulatory plans with Roche’s pipeline and patient access objectives.

Qualifications

• Bachelor’s or Master in Life Science or related subject; advanced degree is an advantage.
• Experience in daily management and continuous improvement practices.

Responsibilities

• Lead submission and registration plans for complex products.
• Manage external interfaces with health authorities and key stakeholders.
• Develop and adapt regulatory strategies to evolving environments and regional needs.
• Influence decision making and negotiate to maximize Roche value.
• Mentor junior staff in regulatory submissions and compliance.
• Collaborate across functions to accelerate global approvals.

Skills

Regulatory affairs

Stakeholder management

Cross-functional leadership

Strategic thinking

Regulatory strategy

Education

Bachelor’s / Master in Life Science

Advanced degree advantage

Job description

Roche is seeking a Senior Regulatory Affairs Manager to shape regulatory strategy for advanced diagnostics and software; lead cross-functional teams through complex, global submissions and lifecycle management. The role involves navigating integrated systems, cybersecurity, and digital technologies with global health authorities.

You will influence decisions across regions, mentor staff, and align regulatory plans with Roche’s pipeline and patient access objectives.