Job Details

Overview

Associate Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction 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 Senior Director in Regulatory Affairs, Advertising and Promotion.

Responsibilities

• 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 chair 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 desired 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 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.

Basic Qualifications

• 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

Preferred Qualifications

• 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.

Compensation and Benefits

Salary range: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For more information about benefits, visit the Kite Careers site. Kite is a biopharmaceutical company focused on CAR-T cell therapies, headquartered in Santa Monica, CA. More information at www.kitepharma.com.

Equal Employment Opportunity

Kite Pharma is an equal employment opportunity employer. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or protected veteran status, and in compliance with applicable laws. Applicants requiring accommodations may contact ...@gilead.com.

For current Kite employees and contractors, please apply via the Internal Career Opportunities portal in Workday.