Senior Manager, Regulatory Affairs CMC

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.

Responsibilities

• 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

Requirements

• 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

Compensation: $177,300-$206,850 base salary