US Company is hiring: Associate Director, Regulatory Affairs Advertising and Pro

Associate Director, Regulatory Affairs Advertising and Promotion

Associate Director, Regulatory Affairs Advertising and Promotion

Locations: United States - Washington - Seattle, United States - California - Foster City

Time Type: Full time

Posted On: Vor 4 Tagen

Job Requisition ID: R0043707

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, ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to 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 for one or more high-volume and/or complex brands or therapeutic areas. You may manage 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 cross-functional process improvements or 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 and communicate relevant updates or changes to cross-functional leaders and teams.

EXAMPLE RESPONSIBILITIES:

• Provides commercial regulatory support to 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 awareness and understanding of FDA regulations, guidance documents, and enforcement actions regarding 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 cross-functional process improvements or other special projects. May contribute to global process improvements.
• Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
• Represents RA Ad/Promo at Regulatory Project Team meetings.
• Mentors RA Ad/Promo and cross-functional 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 with 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.
• 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.
• Experience working with external contractors supporting the work of regulatory affairs is a plus.
• Significant experience participating in cross-functional projects and teams.

Knowledge & Other Requirements

• Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance regulatory strategies for assigned products or projects.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Strong communication and organizational skills.
• When needed, ability to travel.

The salary range for this position is: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics.

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