Gilead Sciences · 5 hours ago
Associate Director, Regulatory Affairs Advertising and Promotion
United States
Full-time
Remote
Director/Executive
$178K/yr - $230K/yr
10+ years exp
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Responsibilities
Provides commercial regulatory support to 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, with managerial oversight, as appropriate.
May lead local cross-functional 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 cross-functional 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.
Qualification
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Required
PharmD/PhD 4+ years’ relevant experience.
MA/MS/MBA with 8+ years’ relevant experience.
BA/BS with 10+ years’ relevant experience.
For external candidates, 4+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products.
Significant experience leading development and execution 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 cross-functional regulatory activities, and representing Regulatory to cross-functional 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.
Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
Significant experience participating in cross-functional projects and teams.
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.
In-depth knowledge of promotional regulations and guidance for prescription drug and biologic products, including industry best practices and standards.
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.
Preferred
Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
Line management (direct reports) experience is a plus.
Experience working with external contractors supporting the work of regulatory affairs is a plus.
Experience authoring and/or implementing processes.
Working knowledge of relevant regulatory or related systems is preferred.
Demonstrates ability to rapidly learn new therapeutic areas.
When needed, ability to travel.
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10,001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (163)
2022 (216)
2021 (218)
2020 (226)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
2017-10-23IPO· bit:GILD
Leadership Team
Patrick Loerch
Senior Vice President, Clinical Data Science
Ahmed Afifi
Vice President - Region Head Latin America
Recent News
Business Wire
2024-11-14
Company data provided by crunchbase
