Director, Regulatory Affairs Advertising and Promotion

About this role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   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 Gilead and help create possible, together.

Job Description   Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multiple high-volume and/or otherwise complex brands or therapeutic areas. You may manage, oversee, and review the work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings for complex brands. You may lead local or global cross-functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross-functional leaders and teams. You may assume a leadership role in advising cross-functional stakeholders on regulations, policies, and enforcement, which may impact Gilead's promotional activities.

Job Responsibilities: • Provides commercial regulatory support to multiple high-volume brands or therapeutic area and projects without managerial oversight, as appropriate.

• Reviews and approves promotional materials. Serves as PRC Chair for one or more high-volume and complex brands or therapeutic areas.

• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.

• Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products.

• May lead local or global cross-functional process improvements or other special projects

• Provides regulatory guidance on new marketing concepts, messaging, and campaigns.

• May be required to assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling, providing strategic regulatory guidance on corporate communications and appropriate pre-approval communications, and/or updating and advising cross-functional stakeholders on regulations, policies, and enforcement, which may impact the company’s promotional activities.

• Oversees or otherwise represents RA Ad/Promo at Regulatory Project Team meetings.

• Oversees or otherwise represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance.

• Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.

Basic Qualifications:

• PharmD/PhD 6+ years’ relevant experience.

OR • MA/MS/MBA with 10+years’ relevant experience.

OR • BA/BS with 12+ years’ relevant experience.

• 4+ years’ experience in regulatory review of promotional materials for prescription drug or biologic products.

Preferred Qualifications: • Significant experience leading development and execution of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.

• Proven track record in effectively directing the commercial regulatory or related strategy to successful conclusion for multiple products.

• Experience chairing/leading promotional review committees or other relevant regulatory governance committees.

• Experience working and negotiating with regulatory authorities is preferred.

• Experience working with external contractors supporting the work of regulatory affairs is a plus.

• Experience authoring and implementing processes.

• Extensive experience participating in cross-functional projects and teams.

• Proven track record of successfully managing large scale, complex, time-sensitive projects.

• Expert knowledge of U.S. regulatory requirements for prescription drug and biologic products.

• Expert knowledge of all key functions involved in the various stages of marketed medicinal products.

• Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.

• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessi

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