Senior Manager, CMC Regulatory Affairs — Submissions Expert

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

Job summary

Cytokinetics is seeking a Senior Manager, Regulatory Affairs – CMC to lead and coordinate regulatory filing strategies for small-molecule programs. You will collaborate with Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain to ensure timely submissions and clear regulatory pathways.

Responsibilities include building high-quality CMC documents, staying current on regulatory intelligence, and supporting interactions with regulatory authorities.

Qualifications

• 5+ years in pharmaceutical/biotech with 2–3 years in Regulatory Affairs-CMC
• Experience compiling technicalregistration dossiers for US/EU

Responsibilities

• Lead/co‑ordinate CMC regulatory filing strategy and submission processes
• Prepare high-quality CMC regulatory documents/packages
• Collaborate with Regulatory Affairs, QA, Technical Operations, and Global Supply Chain
• Monitor regulatory intelligence and evolving requirements impacting CMC plans
• Provide regulatory support for change controls and RIM systems (VEEVA)
• Communicate status, risks and timelines to leadership
• Assist teams in preparation for regulatory authority interactions
• Support department initiatives and regulatory projects

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory intelligence

Written communication

Verbal communication

Influence / issue resolution

Education

Bachelor’s degree in Life Sciences or Pharmacy

Advanced degree preferred

Tools

VEEVA – RIM/EDMS

eCTD submissions (Module 2.3/3)

Job description

Cytokinetics is seeking a Senior Manager, Regulatory Affairs – CMC to lead and coordinate regulatory filing strategies for small-molecule programs. You will collaborate with Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain to ensure timely submissions and clear regulatory pathways.

Responsibilities include building high-quality CMC documents, staying current on regulatory intelligence, and supporting interactions with regulatory authorities.