Director, Regulatory Affairs, Advertising and Promotion

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. Responsibilities Develops and guides implementation strategies for promotional activities • As a member of the Promotional and Medical Review Committees, provides strategic regulatory input during new concept reviews, and reviews and approves materials for regulatory compliance • Assists Commercial Operations in establishing “best practices” for submission of promotional materials into the electronic review system and for the overall promotional material review process • Formulates regulatory strategies, with supervisor oversight, based on current regulatory intelligence and scientific knowledge • Serves as an assigned contact to and maintains a positive relationship with the US FDA Office of Prescription Drug Promotion (OPDP) • Provides promotional regulatory strategy and prepares submission of materials at the time of dissemination (Form FDA 2253) or for advisory comment requests • Maintains up-to-date knowledge and expertise with FDA regulations and guidelines with regards to advertising and promotion of pharmaceutical products and communicates significant changes to relevant stakeholders • Ensures conformance to feedback from various regulatory agencies (eg, OPDP advisory comments) for assigned programs • Builds and maintains relationships across functions and with external partners, including regulatory health authorities, to achieve regulatory goals and facilitate seamless communication • Identifies, develops and implements regulatory operating guidelines and common work practices/strategies within the team Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.