Regulatory Affairs Project Manager / Regulatory Affairs Manager
Roche
full-time
Posted on:
Location Type: Office
Location: Tucson • Arizona • California • United States
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Salary
💰 $84,630 - $157,170 per year
About the role
- Secure regulatory approvals for products by collaborating with cross-functional teams
- Coordinate and compile submission deliverables to ensure all product registrations stay on track
- Maintain product licenses throughout their life cycle, managing Health Authority notifications
- Drive efficiency and success of regulatory strategies by partnering with internal and external entities
- Serve as a subject matter expert, ensuring complex regulatory requirements are communicated and implemented
Requirements
- Bachelor’s or Master’s degree in Life Science, Data Science, or a related field (or equivalent professional experience)
- At least 5 years of experience within Regulatory, R&D, Quality, Operations, and/or Clinical environments
- Experience in diagnostics (highly preferred) or pharmaceutical regulatory affairs
- Experience in companion diagnostics and International markets (APAC preferred) is a plus
Benefits
- Discretionary annual bonus may be available based on individual and Company performance
- Benefits detailed in the link provided
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory approvalsproduct registrationshealth authority notificationsregulatory strategiesdiagnosticspharmaceutical regulatory affairscompanion diagnosticsinternational markets
Soft Skills
collaborationcoordinationcommunicationsubject matter expertiseefficiency
Certifications
Bachelor’s degreeMaster’s degree