Manager, Regulatory Affairs Strategy
Ladders · United States · 6 days ago
RemoteRemoteLegal$116k–$151k/yrFull-time
Responsibilities
- Support global regulatory strategies for late-stage development
- Represent Regulatory Affairs on project teams and influence decision-making
- Cook up submission of INDs, CTAs, and marketing applications
- Lead preparation of critical regulatory documents with subject matter experts
- Facilitate Health Authority interactions and manage follow-ups
- Collaborate with cross-functional teams for registration planning and execution
- Monitor regulatory timelines and manage project deliverables
Qualifications
- Bachelor's degree in Life Sciences required; advanced degree preferred
- 6+ years of regulatory affairs experience in the pharmaceutical or biotechnology sectors
- Experience with clinical-stage development programs and global submissions
- Understanding of FDA, EMA, ICH, and global regulatory requirements
- Experience with IND, CTA preparation, and similar regulatory submissions
- Strong knowledge of late-stage drug development processes
- Familiarity with post-approval change management procedures
Pay
$116,000 – $151,000 annually
Schedule
Remote - US based candidates only, no visa sponsorship available
Benefits
- Comprehensive health insurance and financial offerings
- Wellness and employee support programs
- Life insurance and disability coverage
- Retail plans with employer contributions
- Generous paid time off policies