Global Clinical Trial Submission and Portfolio Senior Manager
Remote
EXPIREDRemoteFull TimeSenior LevelBachelors DegreeEnterprise
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise
Job Summary
Lead global submission management for assets across the product lifecycle, directing the development, quality control and publication of regulatory submissions; drive adherence to external regulatory guidelines and timelines; manage strategic plans, cross-functional teams, and partnerships with product teams and third-party partners; promote document management and archival systems; refine processes for regulatory submissions and operational excellence through collaboration with global regulatory leaders and stakeholders.
Required Qualifications
- BA/BS with 6+ years of experience, or MBA/MS with 5+ years of experience, or PhD/JD with 1+ years of experience, or MD/DVM with 0+ years of experience
- Extensive knowledge in drug development, Regulatory Affairs, and submission management
- Advanced Microsoft Office Suite skills and strong competency with tools
- Strong understanding of regulatory submission processes and requirements
- Excellent analytical and problem-solving abilities
- Effective communication skills, both written and verbal
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