Senior Director, Regulatory Affairs
Locations: South San Francisco, California
Time Type: Full Time
Posted On: Posted Yesterday
Job Requisition ID: R200
About Cytokinetics:
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 for the treatment of diseases where cardiac muscle performance is compromised. As a leader in muscle biology and mechanics, Cytokinetics is advancing small molecule drug candidates engineered to impact myocardial muscle function and contractility.
Job Purpose:
Cytokinetics is seeking an experienced and highly motivated Senior Director, Regulatory Affairs to join the Global Regulatory Affairs team. This role is responsible for developing, implementing, and advising on global regulatory strategies for clinical-stage programs to accelerate and ensure successful product registrations aligned with business objectives.
The Senior Director will provide leadership, regulatory guidance, and mentorship on program strategy and execution, including global regulatory planning, clinical study regulatory requirements, development plans, risk assessments, and Health Authority interactions. This individual will lead the Global Regulatory Team for assigned programs and collaborate cross-functionally with Clinical Research, Drug Safety, Biometrics, Quality, Medical Affairs, and others.
Externally, the Senior Director will interface with Health Authorities and corporate partners regarding development, regulatory, and registration strategies. This position reports to the Executive Director of Regulatory Affairs.
Responsibilities:
Provide strategic regulatory direction for assigned programs, including global regulatory plans, clinical study requirements, development plans, risk assessments, and Health Authority interactions.
Lead the Global Regulatory Team to ensure the successful execution of regulatory plans supporting product approval and commercialization.
Oversee preparation and timely submission of high-quality regulatory documents.
Review sections of IND/CTA, NDA/BLA/MAA submissions, amendments, and associated documents.
Serve as principal interface with US FDA, Health Canada, and other Health Authorities, leading meetings as needed.
Maintain current knowledge of regulatory laws, regulations, and guidelines (FDA, EMA, ICH, PMDA, etc.) and assess their impact on Cytokinetics products.
Provide regulatory expertise and advice as part of the Program Strategy Team to optimize product development.
Participate in regulatory due diligence activities.
Develop and maintain collaborative cross-functional and external relationships to improve regulatory execution.
Mentor department personnel and provide updates on the regulatory environment.
Qualifications:
12+ years of drug development and regulatory affairs experience in the biotech/pharmaceutical industry.
Bachelor of Science in a scientific discipline; advanced degree (MD, PharmD, or PhD) preferred.
Extensive experience in INDs, NDAs, MAAs submissions, lifecycle management, and Health Authority interactions.
Comprehensive understanding of global regulatory requirements for investigational product development and approval.
Strong team player, capable of working collaboratively and independently.
Excellent verbal and written communication skills.
Superior planning, organization, and time management skills, with the ability to prioritize multiple projects.
Strong interpersonal skills and ability to build effective internal and external networks.
Sense of urgency with proactive problem-solving capabilities.
Demonstrated leadership and management expertise.
Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $295,000 - $326,000 USD per year. Base pay offered will consider internal equity, geographic region, job-related knowledge, skills, and experience.
Commitment to Diversity and Inclusion:
Cytokinetics values diverse backgrounds and celebrates differences. We seek the best candidates for open roles and encourage applicants to apply even if they do not meet every qualification. We believe in robust scientific thinking, integrity, and a patient-centered focus, striving to do the right thing in all actions and decisions.
Fraud Warning:
Cytokinetics only extends legitimate offers through our official domain (cytokinetics.com) after a formal interview process. We do not conduct interviews via non-standard text messaging applications, request personal financial information prior to official offer acceptance, or ask candidates to purchase equipment during hiring. Contact talentacquisition@cytokinetics.com if you have any doubts regarding an offer.
Website: www.cytokinetics.com
Equal Opportunity Employer
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