Senior Manager, Regulatory Affairs Advertising and Promotion

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, 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 typically be assigned high-volume brands or therapeutic areas. You will review and approve promotional materials. You will serve as the Promotional Review Committee (PRC) Chair for one or more high-volume brands or therapeutic areas. With management oversight, you will serve as the regulatory liaison for promotional materials for assigned brands to regulatory agencies. You will represent RA Ad/Promo in Regulatory Project Teams and labeling meetings; providing strategic regulatory guidance and seeking advice as needed from other more experienced colleagues. You may initiate and/or contribute to local or global process improvements for activities relating to the work of RA Ad/Promo. You may oversee and manage the work of less experienced colleagues supporting your work. You may coach and advise less experienced colleagues in developing their regulatory capabilities. You will train cross-functional partners and teams on regulatory requirements for promotional materials.

EXAMPLE RESPONSIBILITIES:

• Provides commercial regulatory support to high-volume brands or therapeutic area and projects with minimal managerial oversight, as appropriate. Reviews and approves promotional materials.

• Serves as PRC Chair for one or more high-volume 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.

• May initiate and/or contribute to local or global process improvements for activities relating to the work of RA Ad/Promo.

• Provides regulatory guidance on new marketing concepts, messages, and campaigns, with managerial oversight as needed.

• Represents RA Ad/Promo at Regulatory Project Team meetings.

• Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance, with managerial oversight, as appropriate.

• Seeks assistance from others as needed.

• Mentors RA Ad/Promo team members and provides training to cross-functional team members as needed.

• 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 2+ years’ relevant experience.

• MA/MS/MBA with 6+years’ relevant experience.

• BA/BS with 8+ years’ relevant experience.

• For external candidates, 2+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products.

• Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic products.

• Experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products is strongly preferred.

• Experience chairing/leading promotional review committees or other relevant regulatory governance committees is strongly preferred.

• Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.

• Experience working with external contractors supporting the work of regulatory affairs is a plus.

• Experience authoring and/or implementing processes.

• Experience successfully leading departmental and cross-functional teams without authority.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Demonstrates knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives.

• In-depth knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products, including industry best practices and standards.

• Working knowledge of relevant regulatory or related systems is preferred.

• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills, as evidenced through accomplishments in past roles.

• Ability to lead and influence programs, projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented, highly matrixed environment.

• When needed, ability to travel.