Manager, Regulatory Affairs Advertising and Promotion
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 provide commercial regulatory support for assigned brands, therapeutic area, and other projects. You may review and approve or co‑review/approve promotional materials. You may manage external operational contractor support, including advising on OPDP submission requirements for accelerated approval and launch submissions, as applicable. You may initiate and/or contribute to local process improvements for activities relating to the work of RA Ad/Promo.
You may train cross‑functional partners and teams on promotional material submission requirements. You will assist or serve as the Promotional Review Committee (PRC) Chair for one or more brands or therapeutic areas. With management oversight, you will provide regulatory guidance on new promotional concepts and campaigns. You may represent RA Ad/Promo in Regulatory Project Teams. You may also attend labeling meetings.
Example Responsibilities
- Provides commercial regulatory support to assigned products or therapeutic area and projects with managerial oversight, as appropriate. Conducts co‑review and/or review and approval of promotional materials.
- May train external contractors on Gilead submission processes and advise on submission requirements for promotional materials, including accelerated approval and launch submissions.
- May manage external operational contractors, as necessary.
- May serve as group lead for external operational contractor support, including managing division of responsibilities and coverage plans.
- Provides training to cross‑functional team members on promotional material submission requirements, as needed.
- Assists or serves as PRC Chair for one or more 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.
- May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion.
- May provide regulatory guidance on new marketing concepts, messages, and campaigns with managerial oversight.
- Represents RA Ad/Promo at Regulatory Project Team meetings as needed.
- May attend labeling meetings as needed, with managerial oversight.
- Seeks assistance from others as needed.
- Supports and helps coordinate the training of new Associates in the Regulatory Ad/Promo group, as needed.
- Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
Requirements
Education & Experience
- PharmD/PhD with some relevant experience.
- MA/MS/MBA with 4+ years’ relevant experience.
- BA/BS with 6+ years’ relevant experience.
- For external candidates, 1+ 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 is preferred.
- Experience working with external operational contractors supporting the work of regulatory affairs is a plus.
- Experience writing or updating processes.
- Experience working in project teams.
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 working knowledge of the role of regulatory affairs in achieving cross‑functional business goals and objectives.
- Knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products.
- 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.