Regulatory Manager – Senior Regulatory Manager, Clinical Trials
Precision For Medicine
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇸🇰 Slovakia
Visit company websiteJob Level
Senior
About the role
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
- Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
- Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
- 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 for contracted programs
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
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory guidanceclinical developmentregulatory submissionscompliance standardsdocument reviewstrategic regulatory inputproject managementsubmission targets
Soft skills
leadershipcommunicationcoordinationteamwork