Senior Director, Advertising and Promotion Regulatory Affairs

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: May 28, 2025

Job Description:

Senior Director, Advertising and Promotion Regulatory AffairsJob DescriptionWe're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job DescriptionThe Senior Director, Regulatory Affairs, Advertising and Promotion is responsible for developing and executing a regulatory strategy that enables the global business to meet its needs in full compliance. This role is based at Kite, a Gilead Company, in Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs.Responsibilities:Lead, develop, and mentor a team of regulatory advertising and promotion professionals, including a Review team, and an Operations team.Oversee the financial accountability and resourcing responsibilities for assigned staff.Advising Company stakeholders on regulatory changes, policies, and enforcement actions that may impact promotional activities.Assume a leadership role in advising cross-functional stakeholders on the promotional regulatory impact of new campaign concepts, target, or product labeling, and to provide strategic regulatory guidance on corporate communications and appropriate pre-approval and/or disease education communications with minimal oversight.Review/approve promotional, corporate, and other non-promotional materials focused on cellular therapy for cancer to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.Represent the regulatory perspective at and chairing the executive promotional review committee (EPRC) which includes cross functional partners from Commercial, Medical Affairs, and LegalEnhances collaboration across a matrixed organization while developing and maintaining constructive relationships.May serve as the company's regulatory 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.Characterize the advertising and promotion perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues.Review and interpret enforcement letters, keep current with industry changes relating to advertising and promotion, interpret new Guidance to Industry and evaluate related internal policies/best practices and processes.Basic QualificationsAdvanced Degree: Advanced scientific degree (e.g., MD, PharmD, PhD) with 10+ years of relevant experience; ORMaster's Degree: Master's Degree with 12+ years of relevant experience; ORBachelor's Degree: Bachelor's Degree with 14+ years of relevant experiencePreferred Qualifications:An advanced degree and at least 10 years of experience in regulatory review of promotional materials for prescription drug and/or biologic productsRelevant oncology experience; cell/gene therapy experienceA solid understanding of clinical study design, statistical analyses for promotional claims assessment, and comprehensive experience with labeling regulations and U.S./global promotional reviews.Strong decision-making and problem-solving skills, demonstrated by complex reasoning and risk management assessments.A proven track record in influencing cross-functional teams and engaging effectively with senior management.Superior project management and presentation skills, with the ability to work autonomously with minimal oversight from a senior regulatory affairs professionalExpert level of applied knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments.Knowledgeable resource for regulatory advice on promotional, corporate, and other non-promotional initiatives in other departmentsDirect experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling BranchJob DescriptionWe're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job DescriptionThe Senior Director, Regulatory Affairs, Advertising and Promotion is responsible for developing and executing a regulatory strategy that enables the global business to meet its needs in full compliance. This role is based at Kite, a Gilead Company, in Santa Monica, CA, and will report to an Executive Director in Regulatory Affairs.Responsibilities:

• Lead, develop, and mentor a team of regulatory advertising and promotion professionals, including a Review team, and an Operations team.
• Oversee the financial accountability and resourcing responsibilities for assigned staff.
• Advising Company stakeholders on regulatory changes, policies, and enforcement actions that may impact promotional activities.
• Assume a leadership role in advising cross-functional stakeholders on the promotional regulatory impact of new campaign concepts, target, or product labeling, and to provide strategic regulatory guidance on corporate communications and appropriate pre-approval and/or disease education communications with minimal oversight.
• Review/approve promotional, corporate, and other non-promotional materials focused on cellular therapy for cancer to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
• Represent the regulatory perspective at and chairing the executive promotional review committee (EPRC) which includes cross functional partners from Commercial, Medical Affairs, and Legal
• Enhances collaboration across a matrixed organization while developing and maintaining constructive relationships.
• May serve as the company's regulatory 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.
• Characterize the advertising and promotion perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues.
• Review and interpret enforcement letters, keep current with industry changes relating to advertising and promotion, interpret new Guidance to Industry and evaluate related internal policies/best practices and processes.Basic Qualifications
  • Advanced Degree: Advanced scientific degree (e.g., MD, PharmD, PhD) with 10+ years of relevant experience; OR
  • Master's Degree: Master's Degree with 12+ years of relevant experience; OR
  • Bachelor's Degree: Bachelor's Degree with 14+ years of relevant experiencePreferred Qualifications:
    • An advanced degree and at least 10 years of experience in regulatory review of promotional materials for prescription drug and/or biologic products
    • Relevant oncology experience; cell/gene therapy experience
    • A solid understanding of clinical study design, statistical analyses for promotional claims assessment, and comprehensive experience with labeling regulations and U.S./global promotional reviews.
    • Strong decision-making and problem-solving skills, demonstrated by complex reasoning and risk management assessments.
    • A proven track record in influencing cross-functional teams and engaging effectively with senior management.
    • Superior project management and presentation skills, with the ability to work autonomously with minimal oversight from a senior regulatory affairs professional
    • Expert level of applied knowledge of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments.
    • Knowledgeable resource for regulatory advice on promotional, corporate, and other non-promotional initiatives in other departments
    • Direct experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling BranchThe salary range for this position is: $221,000.00 - $286,000.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also 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*.For additional benefits information, visit:https://www.gilead.com/careers/compensation-benefits-and-wellbeing* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
      Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .
      For jobs in the United States:Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
      For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
      YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.Share:Job Requisition ID R0045458Full Time/Part Time Full-TimeJob Level DirectorClick below to return to the Gilead Careers siteClick below to see a list of upcoming eventsClick below to return to the Kite, a Gilead company Careers site
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