Regulatory Affairs Manager
Roche
full-time
Posted on:
Location Type: Office
Location: Arizona • New Jersey • United States
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Salary
💰 $106,100 - $197,000 per year
About the role
- You oversee regulatory document and submission compilation.
- You develop and manage parts of comprehensive global regulatory submissions and registration plans.
- You build effective and enduring external relationships and apply effective stakeholder management practices.
- You lead the organization to adapt to the evolving regulatory environment and requirements.
- You create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
Requirements
- You have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience.
- 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
- Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
- Knowledge of the European, US, China and other international regulations.
- Demonstrated the ability to manage more complex work and/or at parts of global projects.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Comprehensive global regulatory submissions and registration plans benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsregulatory strategiesstakeholder managementDaily ManagementContinuous Improvementregulatory document compilationregistration plansglobal project management
Soft Skills
relationship buildingadaptabilityinfluencing