Director, Regulatory Affairs Advertising and Promotion

Director, Regulatory Affairs Advertising and Promotion

United States – Remote Regulatory Regular

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T‑cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

POSITION OVERVIEW :

Regulatory Affairs Advertising and Promotion (RA Ad / Promo) is a core function within Kite’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 Kite’s commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead / Kite 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 will manage the commercial regulatory strategy and execution of such for multiple high‑volume and / or otherwise complex CAR T‑cell therapy brands or oncology therapeutic areas. You will represent the commercial regulatory perspective at high‑volume Promotional Review Committee (PRC) meetings for complex brand(s). You may lead local or global cross‑functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross‑functional leaders and teams. You may assume a leadership role in advising cross‑functional stakeholders on regulations, policies, and enforcement, which may impact Kite’s promotional activities.

EXAMPLE RESPONSIBILITIES :

• Serves as the commercial regulatory lead for one or more high‑volume and complex brands or therapeutic areas without managerial oversight, as appropriate.
• Review of promotional, corporate, and other non‑promotional materials to assess for compliance with applicable regulations, guidances, and internal policies / best practices.
• 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 / CBER / APLB for assigned product(s) and ensures materials are submitted to FDA in a timely manner.
• May lead local or global cross‑functional process improvements or other special projects.
• Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
• May be required to assume a leadership role in advising cross‑functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling, providing strategic regulatory guidance on corporate communications and appropriate pre‑approval communications, and / or updating and advising cross‑functional stakeholders on regulations, policies, and enforcement, which may impact the company’s promotional activities.
• Represents RA Ad / Promo at Regulatory Project Team / Labeling meetings and provides strategic regulatory guidance.
• Ensures the team and the assigned work comply 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

Knowledge & Other Requirements

The salary range for this position is : $191,250.00 - $247,500.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off and a benefits package. Benefits include company‑sponsored medical, dental, vision and life insurance plans

For additional benefits information, visit : https : / / www.gilead.com / careers / compensation-benefits-and-wellbeing

For jobs in the United States :

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised on diverse perspectives, backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex age sexual orientation physical or mental disability, genetic information or characteristic gender identity and expression veteran status and other non‑job related characteristics or other prohibited grounds specified in applicable federal 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.

For more information about equal employment opportunity protections, view the ‘Know Your Rights’ poster.

NOTICE : EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinions.

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