Senior Director, Regulatory Affairs

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 in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically 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. The Senior Director will be responsible for developing, implementing and advising on global regulatory strategies for clinical stage programs to accelerate and ensure successful product registrations in line with business objectives.

This individual will provide leadership, regulatory guidance and mentorship on program strategy and execution including the global regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments and Health Authority interactions, while ensuring that the latest regulatory requirements and industry standards are met. The Senior Director, Regulatory Affairs will lead the Global Regulatory Team for an assigned program and work cross-functionally with Clinical Research, Drug Safety, Biometrics, Quality, Medical Affairs, and others to advance the development, approval and lifecycle management of assigned programs.

Externally, the individual will interface with Health Authorities and corporate partners in regards to development, regulatory, and registration strategies. He/she will support/lead development and implementation of department policies. The individual will also maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs. This position will report to the Executive Director of Regulatory Affairs.

Responsibilities

• Provides strategic regulatory direction for assigned programs including the global regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, and Health Authority interactions
• As the leader of the Global Regulatory Team, ensures the successful implementation and execution of regulatory plans to support product approval and commercialization.
• Oversees coordination, preparation and timely submission of high-quality regulatory documents.
• Reviews sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
• Serves as a principal interface with US FDA, Health Canada and other Health Authorities as needed. Leads meetings with Health Authorities.
• Maintains current knowledge of laws, regulations and guidelines (FDA, EMA, ICH, PMDA and others as required) and assess the impact of any changes on Cytokinetics products.
• As part of the Program Strategy Team, provides regulatory expertise and advice to other functional areas to optimize product development.
• Participates in regulatory due diligence activities.

• Develops and maintains collaborative relationships with cross-functional teams to improve effectiveness in execution of regulatory strategies.
• Develops and maintains cooperative relationships with corporate partners and external vendors.
• Mentors department personnel and updates appropriate departments on the current 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 submitting INDs, NDAs, and MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, and developing and implementing complex regulatory strategies
• Comprehensive understanding and applied knowledge of global regulatory requirements for the development and approval of investigational products
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong interpersonal capabilities and ability to build and maintain networks. Ability to work effectively across teams, functions and with outside partners.
• Possesses sense of urgenc