Associate Director, Regulatory Affairs (CMC)
Ladders · United States · Yesterday
RemoteRemoteLegal$164k–$213k/yrFull-time
Responsibilities
- Lead the development and execution of regulatory CMC strategies for development and post-approval programs
- Plan and coordinate regulatory submissions for development projects and products
- Author high-quality CMC sections for IND/IMPD, NDA/MAA submissions
- Identify and manage key CMC content requirements with cross-functional teams
- Review and approve CMC change control documents for compliance and quality assurance
- Interpret EMA/ICH/WHO regulations relevant to CMC content in filings
- Stay current on relevant regulatory regulations and guidance documents
Qualifications
- Bachelor's degree required; advanced degree preferred
- 5-7 years of experience in pharmaceutical development and regulatory CMC
- Prior experience in GMP environments
- Knowledge of EU/ICH regulations for small molecules and biologics
- Understanding of global regulatory guidance and interrelated development functions
Benefits
- Comprehensive medical, dental, and vision coverage
- Generous paid time off and flexible work schedules
- 401(k) plan with competitive company match and equity awards
- Access to learning and development programs through a learning institute
- Employee resource groups and community service opportunities