Associate Director, Regulatory Affairs - Advertising and PromotionUnited States – RemoteRegulatoryRegular
At Kite, our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team, and together we can continue making a positive impact in the cancer field.
The Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in support of patients and in a compliant manner. Responsibilities pertain primarily to US marketing activities focused in cell therapy. The Associate Director will report to a Director in Regulatory Affairs, Advertising and Promotion.
- 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).
- 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 required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.
- 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 expert commercial regulatory guidance.
- Characterization of the regulatory promotional perspective and rationale 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.
- Doctorate and 2+ years of relevant industry experience OR
- Master’s and 8+ years of relevant industry experience OR
- Bachelor’s and 10+ years of relevant industry experience OR
- Associate and 12+ years of relevant industry experience OR
- High 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.
- Direct 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 required.
- 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.
** Remote based employees will be considered for this role **
Does this sound like you? If so, apply today!