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Associate Director, Advertising and Promotion Regulatory Affairs

Associate Director, Advertising and Promotion Regulatory Affairs

Gilead Sciences, Inc.Santa Monica, CA, United States
30+ days ago
Job type
  • Full-time
Job description
  • Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies / best practices.
  • Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal).
  • Serve as a liaison to the FDA’s Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner.
  • Ability to understand and evaluate all perspectives and provide experienced professional commercial regulatory guidance.
  • Characterization of the regulatory promotional perspective and reason at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the PRC.
  • Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies / best practices and processes.Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.Doctorate and 2+ years of relevant industry experience ORMaster’s and 8+ years of relevant industry experience ORBachelor’s and 10+ years of relevant industry experience ORAssociate and 12+ years of relevant industry experience ORHigh School Diploma / GED and 14+ years of relevant industry experience
  • Regulatory review of promotional materials for prescription drug and / or biologic products
  • Oncology, immunology, and / or other relevant therapeutic area experience is desirable.
  • An advanced degree is also desirable.
  • Experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
  • Excellent verbal and written communication skills and interpersonal skills are desired.
  • Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
  • Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities.
  • The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate and other non-promotional initiatives in other departments.Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

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    Regulatory Promotion • Santa Monica, CA, United States