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Job description
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. The Associate Director, Regulatory Affairs reports to the Executive Director of Regulatory Affairs and performs hands‑on regulatory activities across development stages, ensuring high‑quality submissions and effective interactions with health authorities.
Responsibilities
Regulatory Strategy and Program Support
Contribute to development and execution of regulatory strategies for assigned programs and serve as regulatory lead for assigned clinical studies
Identify potential regulatory risks and develop mitigation approaches
Provide regulatory guidance throughout product development to cross‑functional teams such as study operating teams and assigned workstreams
Lead preparation, review, and timely submission of high‑quality, compliant regulatory documents (INDs, CTAs, amendments; NDAs, supplements) and moderately complex regulatory submissions
Contribute to department initiatives, including the development and maintenance of internal regulatory processes, operating guidelines, templates, and best practices
Health Authority Engagement
Support preparation for health authority interactions, including briefing packages and response documents
Participate in agency communications and help track commitments and action items
Regulatory Intelligence and Compliance
Stay current with evolving global regulatory requirements, including therapeutic area‑specific guidances and scientific developments, and assess potential impact on programs
Ensure regulatory activities are conducted in accordance with applicable regulations and company procedures
Qualifications
Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus
8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
Excellent working knowledge of global regulatory requirements (FDA, EMA, ICH), including an understanding of GXP
Experience supporting regulatory submissions (e.g., IND/CTA/eCTD) and health authority interactions
Proven ability to manage multiple priorities and work effectively across teams, functions and with external partners
Excellent written and verbal communication skills
Excellent organizational and product coordination skills
Pay Range
In the U.S., the hiring pay range for fully qualified candidates is $200,700‑$234,150 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job‑related knowledge, skills, and experience among other factors.
Cytokinetics is an Equal Opportunity Employer.
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.