Senior Specialist, Regulatory Pharmacologist-Promotions at ImmunityBio in Summit, NJ

Job description

Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Senior Specialist Regulatory Pharmacologist - Promotions is responsible for the review and contribute to the approval of all US promotional materials and serve as the promotional regulatory consultant interacting with marketing, legal, and medical teams and as a member of the promotional review committee to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives. Essential Functions Contribute to the management of correspondence with FDA’s promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comments. Contribute to the proposal of creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. Contribute to the development and implementation of US marketing strategy and promotional programs. Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives. Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate significant changes in FDA perspective to relevant stakeholders Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review. Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor’s degree with an emphasis in science, health care or related fields with 7+ years of pharmaceutical/biologics industry or related experience with an empha