Regulatory Affairs Manager
Roche
full-time
Posted on:
Location Type: Office
Location: Tucson • Arizona • New Jersey • United States
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Salary
💰 $106,100 - $197,000 per year
About the role
- Oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs.
- Develop and manage parts of comprehensive global regulatory submissions and registration plans.
- Interface with external management.
- Build effective and enduring external relationships and apply effective stakeholder management practices.
- Contribute to audits by supporting preparation, execution and follow up.
- Lead the organization to adapt to the evolving regulatory environment and requirements.
- Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.
Requirements
- 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.
- Experience with CLIA Regulations.
- Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
- Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
- Demonstrated ability to manage more complex work and/or parts of global projects.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Health insurance
- Retirement plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory document compilationsubmission/product registrationglobal regulatory submissionsregulatory strategiesCLIA Regulationsquality standardsDaily ManagementContinuous ImprovementIVDsMedical devices
Soft Skills
stakeholder managementrelationship buildingauditing supportadaptabilityinnovationinfluencingcommunicationleadershipproblem-solvingproject management