Vice President, Regulatory Affairs Cytokinetics
Cytokinetics is dedicated to the discovery, development and commercialization of therapeutics leveraging our expertise in the area of the cytoskeleton and the biology of muscle function to pursue new treatments for multiple diseases. We are committed to innovation that has translated our focus on the cytoskeleton into a Research and Development pipeline that to date has sent five first-in-class compounds into the clinic. Each program we are pursuing directs a unique mechanism of action toward an entirely novel therapeutic approach to an important unmet clinical need.
The Vice President of Regulatory Affairs is responsible for leading the activities of the Regulatory Affairs group at Cytokinetics with emphasis on global regulatory strategy and the preparation, review and evaluation of documents for submission to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the CEO and be a member of the executive committee.
o Formulates and oversees implementation of regulatory strategy and activities needed to secure approval of new drugs.
o Manages coordination, preparation and timely submission of regulatory documents.
o Maintains expert knowledge of and familiarity with FDA/EMA regulations and ICH guidelines.
o Provides regulatory advice to other functional areas and collaborates with internal partners to improve the effectiveness of Cytokinetics? regulatory strategies.
o Directs due diligence activities related to regulatory affairs, prior experience in co-development collaborations preferred.
o Develops and maintains relationships with external vendors and health care regulatory authorities.
o Manages all activities pertaining to interactions with FDA, EMA, and other health care regulatory authorities, and communicates outcomes to senior management.
o Supervises consultants and contractors to the Regulatory Affairs department.
o Develops and implements standard operating procedures and common work practices within the team.
o Responsible for overseeing the Quality Assurance function.
o If an MD, may also be responsible for the Drug Safety function.
o 15+ years of drug development and regulatory affairs experience in the biotechnology or pharmaceutical industry with a minimum of 5 years in a leadership role.
o An advanced degree in the biological sciences (MD, PhD, or PharmD) is required; an MD is strongly preferred.
o Experience with Orphan Drug & Rare Disease regulatory support and strategy is required.
o Demonstrated knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA), and prosecution of NDAs through review to a final decision by health care regulatory authorities, specifically including FDA and EMA.
o Demonstrated expert knowledge of and familiarity with the regulations and practices of FDA, EMA, and other major health care regulatory authorities.
o Experience with the regulatory aspects of development programs for therapeutics directed toward neuromuscular and/or cardiovascular diseases is highly desirable.
o Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP compliance is a strong plus.
o Prior experience with post marketing/Phase IV studies desired.
o Prior experience with open label extension studies and expanded access programs desired.
o Demonstrated management expertise, including the leadership and professional development of employees.
o Demonstrated ability to work independently with exceptional organization and attention to detail.
o Excellent oral and written communication and presentation skills.
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