Director, Regulatory Affairs Advertising and Promotion

Kite Pharma Regulatory Affairs Advertising And Promotion

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. Join Kite and help create more tomorrows.

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.

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 ensure 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 :