Regulatory Manager – Senior Regulatory Manager
Precision For Medicine
full-time
Posted on:
Location Type: Remote
Location: Poland
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Salary
💰 PLN 190,200 - PLN 285,400 per year
Job Level
About the role
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities
- Develops and/or reviews documents for submission to Regulatory Authorities and/or Ethics Committees
- Serve as representative of Global Regulatory Affairs at project team meetings
- Works within a project team, and where necessary, leads project for the region or globally
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets
Requirements
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
- Computer literacy (MS Office/ Office 365)
- Fluent in English
Benefits
- private medical insurance
- MultiSport Card
- life insurance
- pension
- home working allowance
- vacation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory guidanceclinical developmentdocument reviewapplication compilationsubmission to Regulatory Authoritiessubmission to Ethics Committeesproject managementleadership in project teamssubmission targets achievement
Soft Skills
communicationcoordinationteam leadership