Senior Manager, Regulatory Affairs Advertising and Promotion - Cell Thearapy Products

Kite Pharma

About The Position

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.

Requirements

PharmD/PhD 0+ years’ relevant experience.
MA/MS/MBA with 6+ years’ relevant experience.
BA/BS with 8+ years’ relevant experience.
Demonstrates knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives.
In-depth knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products, including industry best practices and standards.
Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills, as evidenced through accomplishments in past roles.
Ability to lead and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Proven ability to work successfully in a team-oriented, highly matrixed environment.
When needed, ability to travel.

Nice To Haves

For external candidates, 2+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products.
Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic products.
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 is strongly preferred.
Experience chairing/leading promotional review committees or other relevant regulatory governance committees is strongly preferred.
Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
Experience working with external contractors supporting the work of regulatory affairs is a plus.
Experience authoring and/or implementing processes.
Experience successfully leading departmental and cross-functional teams without authority.
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 where needed.
Working knowledge of relevant regulatory or related systems is preferred.

Responsibilities

Provides commercial regulatory support to high-volume brands or therapeutic area and projects with minimal managerial oversight, as appropriate.
Reviews and approves promotional materials.
Serves as the commercial regulatory lead for one or more high-volume brands or oncology 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/CBER/APLB for assigned products, with managerial oversight.
May initiate and/or contribute to local or global process improvements for activities relating to the work of RA Ad/Promo.
Provides regulatory guidance on new marketing concepts, messages, and campaigns, with managerial oversight as needed.
Represents RA Ad/Promo at Regulatory Project Team meetings.
Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance, with managerial oversight, as appropriate.
Seeks assistance from others as needed.
Mentors RA Ad/Promo team members and provides training to cross-functional team members as needed.
Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

Benefits

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.

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