Director, Regulatory Affairs Advertising and Promotion

Gilead Sciences•Foster City, CA

1d•$210,375 - $272,250

About The Position

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.

Requirements

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.

Nice To Haves

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 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 other team members.
When needed, ability to travel.

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.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.