Manager, Regulatory Affairs – Ad/Promo and Labeling

Job Description

Regulatory Affairs Advertising and Promotion (Ad/Promo) and Labeling is a core function within Kite’s Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs (RA) Ad/Promo and labeling provides strategic regulatory guidance and input on Kite’s commercial, corporate communications and contributes to the development of labeling strategy; thereby, playing a critical role ensuring that these activities are complaint with governing laws, regulations, and Kite’s policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Kite’s commercial activities to U.S. regulatory agencies.

You may provide commercial regulatory support for assigned brands, therapeutic areas, and other projects. You may review and approve or co-review/approve promotional materials. 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 and Labeling in Regulatory Project Teams. You may also attend labeling meetings and contribute to the development of the labeling strategy for assigned products and indications as needed. You may contribute to the team review of ex-U.S. labeling as needed. You may train cross-functional partners and teams on promotional material submission requirements. You may oversee and manage the work of less experienced colleagues or contract support as needed. You may initiate process updates and/or other special projects.

Job 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 labeling/promotional materials.
• Assists or serves as PRC Chair for one or more brands or therapeutic areas
• Represents RA Ad/Promo and Labeling at Regulatory Project Team meetings as needed
• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products
• May attend labeling meetings and contribute to the development of labeling strategy for assigned products and indications with managerial oversight
• With or in lieu of your manager, represents RA Ad/Promo and Labeling on RA Project Teams, at cross-functional submission team meetings, and joint labeling meetings with partner companies
• May serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate
• May initiate and/or contribute to global process improvements

Basic Qualifications

Master’s and 4+ years of regulatory or clinical experience

OR

Bachelor’s and 6+ years of regulatory or clinical experience

OR

High School Diploma/GED and 10+ years of regulatory or clinical experience

Preferred Qualifications

• PhD/PharmD
• Experience working in one or more Kite therapeutic area
• For external candidates, 1+years’ experience in regulatory review of promotions for prescription drugs or other biologic products and/or experience in prescription drug labeling
• Experience guiding development and implementation of regulatory submission of promotional materials for prescription drug or biologic product
• Experience working in project teams
• 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
• 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 biological products
• Working knowledge of regulatory requirements and guidance for the promotion of prescription drug and biological products
• Working knowledge of relevant regulatory or related systems
• Demonstrates excellent analytical thinking skills, attention-to-detail, thorough communication and writing skills, and project management
• Demonstrates increasing familiarity with competitor labeling, USPI requirements, and ex-U.S labeling
• Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional business goals and objectives
• Microsoft Office suite, as evidenced through accomplishments in the past roles
• Ability to lead and influence programs, projects, and/or initiatives
• Deep interpersonal skills and understanding of team dynamics
• Demonstrated ability to work successfully in a team-oriented, highly matrixed environment
• When needed, ability to travel

The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us?

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.