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Regulatory Manager – Senior Regulatory Manager
Precision For MedicineRegulatory Manager overseeing clinical trial compliance and submissions for Precision for Medicine. Guiding regulatory strategy and preparing quality submissions to regulatory authorities.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- private medical insurance
- MultiSport Card
- life insurance
- pension
- home working allowance
- vacation
ATS Keywords
✓ Tailor your resumeApplicant 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