Assoc Director, Regulatory Affairs, Advertising and Promotion

Kite is now recognized as the world leader in Cell Therapy, and our Immuno-Oncology based pipeline has paved the way for exceptional expansion! We are seeking an Associate Director, Regulatory Affairs, Advertising and Promotion to be responsible for providing commercial regulatory strategy and leadership for development stage products. The incumbent will enable the US business to meet its commercial needs in support of patients and corporate compliance. Based in Santa Monica, CA and reporting to the Senior Director in Foster City, CA, responsibilities relate primarily to US marketing activities focused in cell therapy.

Are you ready to be recognized as a resource for advice on regulatory promotional, corporate and other non-promotional initiatives? We encourage you to apply for this opportunity!

Responsibilities Include:

• Review promotional/non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/standard methodologies.
• Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal).
• Assume a leadership role in advising teams on the regulatory impact of new campaign concepts and product labeling, and provide regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight.
• Serve as the company's regulatory liaison to the FDA's Advertising and Promotional Labeling Branch for respective product(s) and ensure materials are submitted to FDA in a timely manner
• 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.

Knowledge, Experience and Skills:

• Requires a BA/BS degree in a related discipline and 10+ years of relevant experience, including 6+ years of regulatory review of promotional materials for prescription drug and/or biologic products. An advanced degree is also desirable.
• Oncology, immunology, and/or other relevant therapeutic area experience is desirable.
• Excellent verbal and written communication skills and interpersonal skills are required.
• Capable of developing and implementing commercial regulatory strategy and facilitating complex negotiations with internal and external partners.
• Update and advise Company partners on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.
• Work is performed with minimal direction from a senior Regulatory Affairs professional.
• Direct experience working with FDA's Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.

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.

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