Hiring: Associate Director, Regulatory Affairs Company: Cytokinetics Location: San Francisco Bay Area Job Posted Time: 2026-09-11 10:57:13 Target Skills & Keywords : GDPR About the job Experience: •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. •8+ years of drug development, including 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry •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. Required Skills: •Y 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 •Support preparation for health authority interactions, including briefing packages and response documents •Participate in agency communications and help track commitments and action items Qualifications: •Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus •Excellent working knowledge of global regulatory requirements (FDA, EMA, ICH), including an understanding of GXP •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 Compensation: •$200,700 - $234,150 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!