Senior Director, Regulatory Affairs - Development Strategy
Ladders · United States · 1 wk ago
RemoteRemoteLegal$222k–$303k/yrFull-time
Responsibilities
- Lead development and execution of global regulatory strategies for assigned programs
- Identify and assess regulatory risks and define risk-mitigation strategies
- Provide regulatory guidance across functions in the R&D process
- Direct planning and coordination of global regulatory submissions
- Oversee preparation of effective regulatory submission documentation
- Prepare and deliver materials for regulatory agency meetings
- Monitor and interpret global regulatory agency activities and their potential impacts
Qualifications
- Bachelor's degree in life sciences or related field
- 8+ years of experience in Regulatory Affairs
- Hands-on experience with regulatory submissions in multiple regions (US, EU, etc.)
- Strong knowledge of global regulatory requirements and eCTD submission formats
- Experience in managing complex regulatory deliverables throughout product lifecycle
- Excellent submission writing and review skills
- Significant experience interacting with FDA and EMA
Benefits
- Comprehensive medical, dental, and vision coverage
- Generous paid time off and flexible work schedules
- 401(k) with competitive company match and annual equity awards
- Access to learning and skill-building resources
- Employee resource groups and service programs