Job details

Senior Manager, Regulatory Affairs CMC

Cytokinetics is a biopharmaceutical company focused on developing treatments for heart-related diseases. They are looking for a Senior Manager in Regulatory Affairs - CMC to lead regulatory submissions and collaborate with internal teams.

Skills

Regulatory knowledge
Project management
Documentation expertise
Interpersonal skills
Communication skills

Responsibilities

Lead and coordinate CMC regulatory filing strategy.
Prepare high quality CMC regulatory documents.
Collaborate with internal stakeholders.
Maintain knowledge of regulatory processes.
Provide regulatory support for quality systems.
Communicate status and risks on regulatory strategies.

Education

Bachelor’s degree in a related discipline
Advanced degree preferred

Benefits

Equal Opportunity Employer
Diversity celebration
GDPR compliant hiring process

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CEO of Cytokinetics

Robert I. Blum

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By Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class therapies for debilitating diseases.

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