Job Description

Associate Director, Regulatory Affairs Advertising and Promotion

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 crossfunctional 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 one or more 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 crossfunctional 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 crossfunctional leaders and teams.

EXAMPLE RESPONSIBILITIES:

• Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate.
• 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, with managerial oversight, as appropriate.
• May lead local crossfunctional process improvements or other special projects. May initiate and/or contribute to global process improvements.
• Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
• Represents RA Ad/Promo at Regulatory Project Team meetings.
• Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance.
• Mentors RA Ad/Promo and crossfunctional team members as needed.
• May have one or more direct reports.
• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

• PharmD/PhD 4+ years relevant experience.
• MA/MS/MBA with 8+ years relevant experience.
• BA/BS with 10+ years relevant experience.
• For external candidates, 4+ years experience in regulatory review of promotions for prescription drugs or other biologic products.

• Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug or biologic products.
• Significant experience contributing to the development of commercial regulatory or related strategies, leading crossfunctional regulatory activities, and representing Regulatory to crossfunctional teams for multiple products.
• Experience chairing/leading promotional review committees or other relevant regulatory governance committees.
• Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
• Line management (direct reports) experience is a plus.
• Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
• Experience working with external contractors supporting the work of regulatory affairs is a plus.
• Experience authoring and/or implementing processes.
• Significant experience participating in crossfunctional projects and teams.

Knowledge & Other Requirements

• Demonstrates indepth 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 assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
• Indepth knowledge of promotional regulations and guidance for prescription drug and biologic products, including industry best practices and standards.
• Working knowledge of relevant regulatory or related systems is preferred.
• Demonstrates ability to rapidly learn new therapeutic areas.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.
• When needed, ability to travel.

Job Requisition ID R0044546

Full Time/Part Time Full-Time

Job Level Associate Director

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