Director, Regulatory Affairs Advertising and Promotion

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
 

POSITION OVERVIEW:

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.

EXAMPLE RESPONSIBILITIES:

• May lead and manage one or more direct reports. Hires, develops, and retains diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development, and career interests.

• 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.

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 6+ years’ relevant experience.

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

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

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

• 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.

• Line management (direct reports) experience is preferred.

• Proven track record of matrix leadership or effective people leadership and management, as evidenced through past effectiveness with employee engagement, development, and retention of matrix team members or direct reports.

• 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.

Knowledge & Other Requirements

• 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 assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.

• 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. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees.

• Strong negotiation and conflict resolution skills.

• Strong coaching capabilities to mentor/develop direct reports or other team members.

• When needed, ability to travel.

 

The salary range for this position is: $191,250.00 - $247,500.00. Gilead 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.

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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.

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