Manager, Regulatory Affairs - Ad/Promo and Labeling

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: September 22, 2024

Job Description:

Manager, Regulatory Affairs - Ad/Promo and LabelingJob 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 DescriptionRegulatory Affairs Advertising and Promotion (Ad/Promo) and Labeling is a core function within Kite's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs (RA) Ad/Promo and labeling provides strategic regulatory guidance and input on Kite's commercial, corporate communications and contributes to the development of labeling strategy; thereby, playing a critical role ensuring that these activities are compliant with governing laws, regulations, and Kite's policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Kite's commercial activities to U.S. regulatory agencies.You may provide commercial regulatory support for assigned brands, therapeutic areas, and other projects. You may review and approve or co-review/approve promotional materials. You will assist or serve as the Promotional Review Committee (PRC) Chair for one or more brands or therapeutic areas. With management oversight, you will provide regulatory guidance on new promotional concepts and campaigns. You may represent RA Ad/Promo and Labeling in Regulatory Project Teams. You may also attend labeling meetings and contribute to the development of the labeling strategy for assigned products and indications as needed. You may contribute to the team review of ex-U.S. labeling as needed. You may train cross-functional partners and teams on promotional material submission requirements. You may oversee and manage the work of less experienced colleagues or contract support as needed. You may initiate process updates and/or other special projects.Job Responsibilities

• Provides commercial regulatory support to assigned products or therapeutic area and projects with managerial oversight, as appropriate. Conducts co-review and/or review and approval of labeling/promotional materials.
• Assists or serves as PRC Chair for one or more brands or therapeutic areas
• Represents RA Ad/Promo and Labeling at Regulatory Project Team meetings as needed
• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products
• May attend labeling meetings and contribute to the development of labeling strategy for assigned products and indications with managerial oversight
• With or in lieu of your manager, represents RA Ad/Promo and Labeling on RA Project Teams, at cross-functional submission team meetings, and joint labeling meetings with partner companies
• May serve as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate
• May initiate and/or contribute to global process improvementsBasic QualificationsMaster's and 4+ years of regulatory or clinical experienceORBachelor's and 6+ years of regulatory or clinical experienceORHigh School Diploma/GED and 10+ years of regulatory or clinical experiencePreferred Qualifications
  • PhD/PharmD
  • Experience working in one or more Kite therapeutic area
  • For external candidates, 1+ years' experience in regulatory review of promotions for prescription drugs or other biologic products and/or experience in prescription drug labeling
  • Experience guiding development and implementation of regulatory submission of promotional materials for prescription drug or biologic product
  • Experience working in project teams
  • Demonstrated ability to be a fast learner
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise
  • Demonstrates working knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives
  • Knowledge of regulatory requirements and guidance for the promotion of prescription drug and biological products
  • Working knowledge of relevant regulatory or related systems
  • Demonstrates excellent analytical thinking skills, attention-to-detail, thorough communication and writing skills, and project management
  • Demonstrates increasing familiarity with competitor labeling, USPI requirements, and ex-U.S labeling
  • Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional business goals and objectives
  • Microsoft Office suite, as evidenced through accomplishments in the past roles
  • Ability to lead and influence programs, projects, and/or initiatives
  • Deep interpersonal skills and understanding of team dynamics
  • Demonstrated ability to work successfully in a team-oriented, highly matrixed environment
  • When needed, ability to travelThe work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.The salary range for this position is: $130,220.00 - $168,520.00. 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.
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Keywords: Gilead Sciences, Inc., Santa Monica , Manager, Regulatory Affairs - Ad/Promo and Labeling, Executive , Santa Monica, California