Senior Manager, Regulatory Affairs CMC
Cytokinetics · Radnor, PA
RegulatoryFull-time$177k–$207kCompany career page
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Role summary
Cytokinetics seeks a Senior Manager in Regulatory Affairs CMC to lead chemistry, manufacturing, and controls regulatory submissions and strategy execution. The role involves coordinating cross-functional teams to prepare high-quality regulatory dossiers and maintain compliance with global pharmaceutical standards for small molecule programs.
What they're looking for
- 5+ years pharmaceutical, biotechnology, or related industry experience; 2-3 years in Regulatory Affairs-CMC
- Bachelor's degree in science or pharmacy; advanced degree preferred
- Familiarity with global CMC regulatory guidelines and small molecule development requirements
- Knowledge of U.S. and EU pharmaceutical regulations, quality standards, and approval processes
- Experience with eCTD submissions, VEEVA-RIM, change controls, and registration dossier generation preferred
- Understanding of GDP, GMP, and typical regulatory submission processes and timelines
- Strong written and verbal communication skills with ability to influence and resolve conflicts
What you'll be doing
- Lead and coordinate execution of CMC regulatory filing strategy and submission timelines
- Prepare high-quality CMC regulatory documents and packages meeting company standards
- Collaborate with internal stakeholders across regulatory, quality, operations, and supply chain functions
- Monitor regulatory environment changes and inform stage-specific CMC requirements for clinical programs
- Communicate risks and status updates related to regulatory strategies and approvability
Privacy & handoff
This role links to Cytokinetics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.