Director, Global Labeling Regulatory

Job description

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. 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 Director, Global Labeling Regulatory will orchestrate the strategic global development, maintenance, and compliance of product labeling throughout a drug’s lifecycle. This position will manage direct reports and work closely with cross-functional teams to ensure the labeling of investigational and marketed drugs meet the regulatory requirements of global health authorities. Essential Functions Manage the creation and execution of global labeling strategies from early clinical development through commercialization Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance Manage and review the preparation and maintenance of key labeling documents, such as the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes monitoring for regulatory changes and implementing updates Manage the process of updating label content and artwork for packaging and supplies, coordinating with manufacturing and third-party vendors Manage review and approval of label proofs provided by internal and external labeling teams Oversee or advise in negotiations with Regulatory Agencies regarding the content of product labels Direct the preparation of responses to Health Authority comments and questions pertaining to labeling issues Collaborate with other groups when needed to address global labeling or other CMC related matters Manage the assigned projects and performance of members of the global labeling regulatory team Oversight and drafting of label technical specifications May serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications Leadership ability with demonstrated problem solving and decision-making skills Management and oversight of labeling-related change controls Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities Education & Experience Bachelor’s Degree in life sciences or technical discipline with 14+ years of relevant progressive experience required; or Master’s Degree in life sciences or technical discipline with 12+ years of relevant progressive experience required Extensive experience in Global Health Authority Regulatory labeling requirements for both clinical and commercial stage products required Experience in the preparation and submission of CMC modules in eCTD format is a plus Experience managing staff strongly preferred Experience with Veeva Vault preferred Knowledge, Skills, & Abilities Broad knowledge of and experience with Global Health Authority regulatory product labeling requirements and risk minimization for both clinical and commercial stage products Experience working in a complex and matrix environment Strong leadership skills with the ability to direct and develop professional staff Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins Proficient in Electronic Document Management Systems Strong organizational skills, written and oral communication skills, and attention to detail Keen awareness of cultural sensitivities Working Environment / Physical Environment This position works on site in Summit, NJ. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval. This position may need to sit for long periods of time and use various computer programs. This desk-based role involves the close study of scientific and regulatory documents. This position will work closely with scientific colleagues throughout the day, often on a project team basis. This position may also need to travel to meet with Regulatory Agencies, attend conferences, or visit manufacturing sites. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. $227,500 (entry-level qualifications) to $250,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.