Associate Director, Regulatory Affairs Advertising and Promotion
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Locations : United States - California - Foster City
Time Type : Full time
Posted On : Vor 11 Tagen
Job Requisition ID : R0040533
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer working relentlessly to develop therapies that help improve lives and ensure access to these therapies across the globe.
We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination, and a relentless drive to make a difference.
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, ensuring compliance with governing laws, regulations, and Gilead policies while enabling the business to meet its goals and objectives.
You will manage the commercial regulatory strategy and execution for one or more high-volume and / or 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 cross-functional process improvements or special projects and provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands.
Example Responsibilities :
Provides commercial regulatory support to high-volume brands or therapeutic areas 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 awareness and understanding of FDA regulations and guidance regarding 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.
- Leads local cross-functional process improvements or other special projects.
- 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.
- Ensures compliance with established practices, policies, and processes, and any regulatory 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 with 4+ years’ relevant experience.
- MA / MS / MBA with 8+ years’ relevant experience.
- BA / BS with 10+ years’ relevant experience.
- 4+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products for external candidates.
- Significant experience leading development and execution of regulatory submissions of promotional materials.
- Experience chairing / leading promotional review committees or other relevant regulatory governance committees.
- Experience working directly with regulatory agencies in submissions and negotiations is a plus.
- Line management experience is a plus.
- Experience working with external contractors supporting regulatory affairs is a plus.
- Experience authoring and / or implementing processes.
- Significant experience participating in cross-functional projects and teams.
Knowledge & Other Requirements
- In-depth knowledge of current trends in regulatory affairs.
- Demonstrates advanced regulatory and business knowledge and analytical abilities.
- In-depth knowledge of promotional regulations and guidance for prescription drug and biologic products.
- Strong leadership presence and interpersonal skills.
- Strong communication and organizational skills.
- Ability to travel when needed.
The salary range for this position is : $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
Gilead Sciences, Inc. is a biopharmaceutical company committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.
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