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Job Overview
Location
Remote
Job Type
Full-time
Category
HR & Recruiting
Date Posted
May 22, 2026
Full Job Description
đź“‹ Description
- • Senior Manager, Regulatory Writing at Cytokinetics, a specialty cardiovascular biopharmaceutical company with over 25 years of innovation in muscle biology, responsible for authoring and leading the development of critical regulatory documents such as clinical study protocols, CSRs, IBs, and submission materials to support new medicines for cardiac muscle dysfunction.
- • Day-to-day responsibilities include writing, reviewing, and editing complex regulatory documents; leading cross-functional meetings (kickoff, data interpretation, comment resolution); managing multiple writing projects; serving as primary point of contact for submission teams; overseeing vendor work; ensuring scientific accuracy, compliance with ICH/GCP and SOPs; and communicating timelines and deliverables to management.
- • The Regulatory Writing team operates within a mission-driven organization dedicated to improving patient outcomes through scientific excellence, integrity, and ethical practices, collaborating closely with Clinical Research, Biometrics, Drug Safety, Regulatory, and Clinical Pharmacology teams to ensure alignment and quality.
- • In this role, you will deepen your expertise in global regulatory writing, lead high-impact document development for IND/NDA/BLA/MAA submissions, enhance leadership and stakeholder engagement skills, and contribute to process improvements in document management systems and best practices across product teams.
🎯 Requirements
- • BA/BS in life sciences with 8+ years of scientific or medical writing experience in biotech/pharma, or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience
- • Demonstrated ability to lead development of large/complex regulatory documents including CSRs, module 2 summaries, and health authority briefing materials
- • Strong attention to detail with ability to write/summarize science- and data-driven content into clear, concise, and complete documents
- • Excellent project management skills and ability to manage multiple high-priority projects in a fast-paced environment
- • Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP)
- • Ability to oversee consultants/contractors and serve as a liaison for project purposes
🏖️ Benefits
- • U.S. hiring pay range of $173,700 - $202,650 per year for fully qualified candidates
- • Opportunity to work on meaningful cardiovascular therapies that improve patient outcomes and quality of life
- • Remote work flexibility with a company committed to integrity, ethics, and scientific thinking
- • Culture that celebrates diverse backgrounds and values employees as their best selves
- • Exposure to cross-functional leadership and subject matter expert opportunities in document management systems and process initiatives
- • Commitment to professional growth through sharing and implementing Regulatory Writing best practices across teams
Skills & Technologies
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About Cytokinetics, Incorporated
Cytokinetics, Incorporated is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases. Its pipeline targets diseases like amyotrophic lateral sclerosis, chronic heart failure, hypertrophic cardiomyopathy, and spinal muscular atrophy. The company leverages its expertise in muscle biology and contractility to advance small-molecule drug candidates that modulate muscle function, aiming to improve patient outcomes in areas with significant unmet medical need.
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