Associate Director Regulatory Affairs Advertising and Promotion
Associate Director Regulatory Affairs Advertising and Promotion
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$ 165495 - 214170
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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 Gileads Global Regulatory Affairs organization and acts as a critical strategic partner across crossfunctional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gileads 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 Gileads commercial activities to U.S. regulatory agencies.
You will manage the commercial regulatory strategy and of such for one or more highvolume 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 highvolume 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 highvolume brands or therapeutic area and projects without managerial oversight as appropriate. Reviews and approves promotional materials.
Serves as PRC Chair for one or more highvolume 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 8years relevant experience.
BA/BS with 10 years relevant experience.
For external candidates 4 years experience in regulatory review of promotions for prescription or other biologic products.
Significant experience leading development and 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.
For additional benefits information visit:
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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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
Employment Type
Full-Time
