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.
EXAMPLE 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.
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.
Basic Education & Experience
PharmD/PhD 0+ years’ relevant experience.
MA/MS/MBA with 6+ years’ relevant experience.
BA/BS with 8+ years’ relevant experience.
Preferred Requirements
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.
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.
Working knowledge of relevant regulatory or related systems is preferred.
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.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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 of 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, 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.
For more information about equal employment opportunity protections, please 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 a 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 opinion.
Please apply via the Internal Career Opportunities portal in Workday.