Cytokinetics
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Senior Director, Regulatory Affairs
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Cytokinetics .
Read all the information about this opportunity carefully, then use the application button below to send your CV and application. 23 hours ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Company Overview Cytokinetics is a late-stage, specialty cardiovascular 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 affecting cardiac muscle performance. The company specializes in muscle biology and developing small molecule drug candidates to impact myocardial muscle function and contractility. Job Purpose The Senior Director, Regulatory Affairs will lead global regulatory strategies for clinical programs, ensuring successful product registrations aligned with business goals. Responsibilities include providing leadership, regulatory guidance, mentorship, and managing interactions with health authorities. The role involves cross-functional collaboration and external engagement with regulatory bodies and partners, reporting to the Executive Director of Regulatory Affairs. Responsibilities Provide strategic regulatory direction for programs, including global regulatory plans and health authority interactions. Lead the Global Regulatory Team to execute regulatory plans supporting product approval and commercialization. Oversee preparation and submission of regulatory documents. Review IND/CTA, NDA/BLA/MAA, and amendments to ensure regulatory compliance. Interface with FDA, Health Canada, and other authorities, leading meetings as needed. Stay updated on laws, regulations, and guidelines, assessing impacts on products. Offer regulatory expertise to optimize product development as part of the Program Strategy Team. Participate in regulatory due diligence activities. Build relationships with cross-functional teams, partners, and vendors. Mentor department personnel and communicate regulatory updates. Qualifications 12+ years in drug development and regulatory affairs within biotech/pharma. Bachelor's in a scientific discipline; advanced degrees (MD, PharmD, PhD) preferred. Experience in submitting INDs, NDAs, MAAs, and managing regulatory strategies. Deep understanding of global regulatory requirements. Strong team player with excellent communication skills. Effective planning, organization, and multitasking abilities. Leadership experience and ability to develop teams. Pay Range In the U.S., the pay range is $295,000 - $326,000 annually, adjusted based on experience, location, and other factors. We value diversity and encourage applicants from all backgrounds. If you believe you can contribute to Cytokinetics, we look forward to your application. Please review our
GDPR policy
before applying. Our commitment to integrity and patient-centered actions guides us. Beware of fraudulent job offers; legitimate offers will come from our official email domain and after a formal interview process. For authenticity concerns, contact talentacquisition@cytokinetics.com. Visit our website: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer
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Senior Director, Regulatory Affairs
role at
Cytokinetics .
Read all the information about this opportunity carefully, then use the application button below to send your CV and application. 23 hours ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Company Overview Cytokinetics is a late-stage, specialty cardiovascular 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 affecting cardiac muscle performance. The company specializes in muscle biology and developing small molecule drug candidates to impact myocardial muscle function and contractility. Job Purpose The Senior Director, Regulatory Affairs will lead global regulatory strategies for clinical programs, ensuring successful product registrations aligned with business goals. Responsibilities include providing leadership, regulatory guidance, mentorship, and managing interactions with health authorities. The role involves cross-functional collaboration and external engagement with regulatory bodies and partners, reporting to the Executive Director of Regulatory Affairs. Responsibilities Provide strategic regulatory direction for programs, including global regulatory plans and health authority interactions. Lead the Global Regulatory Team to execute regulatory plans supporting product approval and commercialization. Oversee preparation and submission of regulatory documents. Review IND/CTA, NDA/BLA/MAA, and amendments to ensure regulatory compliance. Interface with FDA, Health Canada, and other authorities, leading meetings as needed. Stay updated on laws, regulations, and guidelines, assessing impacts on products. Offer regulatory expertise to optimize product development as part of the Program Strategy Team. Participate in regulatory due diligence activities. Build relationships with cross-functional teams, partners, and vendors. Mentor department personnel and communicate regulatory updates. Qualifications 12+ years in drug development and regulatory affairs within biotech/pharma. Bachelor's in a scientific discipline; advanced degrees (MD, PharmD, PhD) preferred. Experience in submitting INDs, NDAs, MAAs, and managing regulatory strategies. Deep understanding of global regulatory requirements. Strong team player with excellent communication skills. Effective planning, organization, and multitasking abilities. Leadership experience and ability to develop teams. Pay Range In the U.S., the pay range is $295,000 - $326,000 annually, adjusted based on experience, location, and other factors. We value diversity and encourage applicants from all backgrounds. If you believe you can contribute to Cytokinetics, we look forward to your application. Please review our
GDPR policy
before applying. Our commitment to integrity and patient-centered actions guides us. Beware of fraudulent job offers; legitimate offers will come from our official email domain and after a formal interview process. For authenticity concerns, contact talentacquisition@cytokinetics.com. Visit our website: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer
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