Director, Regulatory Affairs, Advertising and Promotion - South San Francisco, United States - Cytokinetics

Description

As the Director of Regulatory Affairs, Advertising and Promotion, you will report directly to the Executive Director, Regulatory Affairs. Your primary responsibility will be to lead commercial regulatory support for assigned programs. You will ensure sound regulatory planning and tactical implementation of US and international promotional strategies.

Responsibilities

Leadership

• While this role is currently an individual contributor, this role may be responsible for supervising consultants, contractors, interns, or providing indirect leadership to members of cross-functional teams.

Functional Area

• Provides commercial regulatory support to assigned products and/or therapeutic areas and collaborates with relevant stakeholders to ensure business objectives can be achieved in a compliant manner. 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 FDA2253) 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

Qualifications

• Bachelor's degree is required, preferably in a scientific discipline; advanced degree is a plus
• Deep knowledge of the regulatory requirements for compliant advertising/promotion and scientific exchange of prescription drug products, including during the investigational and post-approval phases. US regulatory experience required; ex-US regulatory experience is a plus
• Familiarity with Veeva PromoMats and Veeva MedComms preferred
• Proven experience working effectively and influencing others across teams, functions and with outside partners
• Excellent oral and written communication skills, including experience providing creative solutions based on judgement and analysis of the issues
• Excellent organizational skills and attention to detail