Associate Director, Advertising and Promotion Regulatory Affairs
Associate Director, Advertising and Promotion Regulatory Affairs
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$ 165495 - 214170
1 Vacancy
Job Description
Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.
Job Description
At Kite our mission is to improve the lives of people living with cancer. Patients are at the core of everything we do. Join our thoughtful and passionate team and together we can continue making a positive impact in the cancer field.
The Associate Director Regulatory Affairs Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the US business to meet its commercial needs in support of patients and in a compliant manner. Responsibilities pertain primarily to US marketing activities focused in cell therapy. The Associate Director will report to a Senior Director in Regulatory Affairs Advertising and Promotion.
Review of promotionalcorporateand other non-promotional materials to assess for compliance with the applicable regulations guidance documents and internal policies/best practices.
Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includescross functionalpartners from Marketing Medical Affairs and Business Conduct (US Legal).
Assume aleadershiprole in advisingcross-functionalstakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance oncorporatecommunicationsand appropriate pre-approvalcommunicationswith managerial oversight as appropriate.
Serve as a liaison to the FDAs Advertising and Promotional Labeling Branch for respective product(s) and willhelpensure materials are submitted to FDA in a timely manner.
Ability tounderstandand evaluate all perspectives and provide experienced professional commercial regulatory guidance.
Characterization of the regulatory promotional perspective and reason at regulatory project team meetings labeling meetings brand team meetings and asneeded providing training tocross-functionalcolleagues including members of the PRC.
Responsiblefor reviewing and interpreting enforcement letters keeping current with industry changes relating to advertising and promotion interpreting new Guidances to Industry and as applicable evaluating related internal policies/best practices and processes.
Basic Qualifications:
Doctorate and 2yearsofrelevant industryexperience OR
Mastersand8yearsofrelevant industryexperience OR
Bachelorsand10yearsofrelevant industryexperience OR
Associate and 12yearsofrelevant industryexperience OR
High School Diploma/GED and 14yearsofrelevant industryexperience
Preferred Qualifications:
Regulatory review of promotional materials for prescription drug and/or biologic products
Oncology immunology and/or other relevant therapeutic area experience is desirable.
An advanced degree is also desirable.
Experience working with FDAs Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
Excellentverbal and writtencommunication skillsandinterpersonal skillsare desired.
Must be capable of developing and implementing commercial regulatorystrategyand managingcomplexnegotiations with internal and external stakeholders.
Assumes aleadershiprole in updating and advising Company stakeholders on changes in regulations policies and enforcement which may impact the Companys promotional activities.
The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotionalcorporateand other non-promotional initiatives in other departments.
For additional benefits information visit:
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 disabilitygenetic 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 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 for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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. Please apply via the Internal Career Opportunities portal in Workday.
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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:
Required Experience:
Director
Employment Type
Full-Time
