About this role
Role Overview
- Support fluorescence imaging drug products
- Prepare complex submissions for pharmaceutical product approvals
- Assess post-approval changes for regulatory filing categories
- Advise personnel on regulatory pathways and requirements
- Prepare and support submissions for clinical investigations and commercial distribution
Requirements
- Bachelor’s Degree
- 4+ years of experience in an FDA regulated industry
- 2+ years of pre
- and/or post-market Regulatory Affairs experience
- Experience preparing submissions and/ or documents supporting submissions (i.e., CTD summaries)
- Ability to comply with constantly changing regulatory and clinical environments
- Prefer RAC certification or Advanced Degree (Masters in Regulatory Affairs)
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
- bonuses