Regulatory CMC Senior Manager - Drive Global Submissions

Cytokinetics; Radnor (Delaware County); Hybrid; USD 177,000 - 207,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Cytokinetics seeks a Senior Manager, Regulatory Affairs – CMC to lead the regulatory filing strategy for CMC activities across U.S. and international programs.

You will collaborate with Regulatory Affairs, Quality Assurance, Technical Operations, and Global Supply Chain to ensure timely, compliant submissions. You will prepare high-quality CMC documentation, monitor regulatory intelligence, and support or lead cross-functional initiatives, aiming to maintain robust regulatory readiness and

Qualifications

• 5+ years in pharmaceutical/biotech with 2-3 years in Regulatory Affairs-CMC.
• Bachelor’s degree; science or pharmacist major preferred; advanced degree preferred.
• Understanding of U.S. and EU CMC expectations and regulatory guidance.
• Experience generating US/EU technical registration dossiers.
• Familiarity with small molecule development and drug substance/product.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead/co-ordinate execution of CMC regulatory filing strategy and submissions.
• Prepare high-quality CMC regulatory documents per standards.
• Collaborate with Regulatory Affairs, QA, Technical Operations, and Global Supply Chain.
• Monitor regulatory intelligence and environment changes impacting CMC.
• Provide regulatory support for quality processes and systems like change controls and VEEVA RIM.
• Communicate status and risks to defined regulatory strategies and timelines.
• Prepare materials for regulatory authority interactions and internal communications.
• Support or lead department initiatives and training.

Skills

Regulatory strategy

CMC submissions

Stakeholder collaboration

Regulatory intelligence

Leadership

Education

Bachelor's degree

Advanced degree preferred

Tools

VEEVA RIM

eCTD submissions

GDP/GMP knowledge

Job description

Cytokinetics seeks a Senior Manager, Regulatory Affairs – CMC to lead the regulatory filing strategy for CMC activities across U.S. and international programs.

You will collaborate with Regulatory Affairs, Quality Assurance, Technical Operations, and Global Supply Chain to ensure timely, compliant submissions. You will prepare high-quality CMC documentation, monitor regulatory intelligence, and support or lead cross-functional initiatives, aiming to maintain robust regulatory readiness and