Senior Manager, CMC Regulatory Affairs – Global Submissions

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

Job summary

Cytokinetics is seeking a Senior Manager, Regulatory Affairs – CMC to join its cardiovascular biopharmaceutical team. You will lead the execution of CMC regulatory filing strategy and coordinate cross-functional efforts with Regulatory Affairs, Quality Assurance, Technical Operations, and Global Supply Chain.

Responsibilities include preparing high-quality CMC documents, staying current on global regulations for small molecules, and guiding submissions to the US and EU.

Qualifications

• Bachelor’s degree or equivalent; science or pharmacist major preferred.
• 5+ years in pharmaceutical/biotech with 2–3 years in Regulatory Affairs-CMC.
• Familiar with global regulatory guidelines for small molecules.
• Understanding of U.S. and EU regulatory expectations for pharma products.
• Experience generating a technical registration dossier for US/EU.
• Strong communication and cross-functional collaboration skills.
• GDP and GMP understanding.

Responsibilities

• Lead/co-ordinate execution of CMC regulatory filing strategy.
• Prepare high quality CMC regulatory documents in line with company standards.
• Collaborate with Regulatory, QA, Technical Operations and Global Supply Chain.
• Monitor regulatory intelligence and changes impacting CMC planning.
• Provide regulatory support for change controls and VEEVA-RIM processes.
• Communicate status and risks to regulatory strategies and timelines.
• Assist preparation of materials for regulatory authority interactions.
• Lead or participate in non-program-specific projects.

Skills

Regulatory affairs

CMC submissions

Global regulations

US/EU regulations

Interpersonal skills

Influence & negotiation

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva RIM

eCTD software

Job description

Cytokinetics is seeking a Senior Manager, Regulatory Affairs – CMC to join its cardiovascular biopharmaceutical team. You will lead the execution of CMC regulatory filing strategy and coordinate cross-functional efforts with Regulatory Affairs, Quality Assurance, Technical Operations, and Global Supply Chain.

Responsibilities include preparing high-quality CMC documents, staying current on global regulations for small molecules, and guiding submissions to the US and EU.