Principal Specialist, Global Labeling Regulatory

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 Principal Specialist, Global Labeling Regulatory is responsible for the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. The role will ensure all labeling for investigational and marketed drugs meet the regulatory requirements of global health authorities. 

The Principal Specialist will also participate in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and the preparation of dossiers in Electronic Common Technical Document (eCTD) format. The Principal Specialist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs).

Essential Functions

• Create and execute global labeling strategies from early clinical development through commercialization.
• Contribute to writing and maintaining key labeling documents, such as the Company Core Data Sheet (CCDS), 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.
• Act as the primary labeling representative on various project teams, coordinating with departments like Clinical, Safety, Medical Affairs, Quality, Commercial, and Supply Chain.
• Manage the process of updating label content and artwork for packaging and supplies, coordinating with manufacturing and third-party vendors.
• Advise internal stakeholders on labeling content, processes, timelines, and potential risks, and present labeling strategies to senior leadership.
• Lead or support negotiations with Regulatory Agencies regarding the content of product labels.
• Assist with preparation and review Module 2 (QOS) and Module 3 documents in accordance with eCTD guidance and company standards.
• Contribute to the development of global CMC regulatory strategies.
• Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation.
• Assist with the preparation of responses to Health Authority comments and questions pertaining to labeling issues.
• Develop and adhere to Standard Operating Procedures (SOPs) and process improvements as needed.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree with 10+ years’ experience working on clinical and commercial labels for varied types of drug products in a global setting required; or
• Master’s degree with 8+ years of experience working on clinical and commercial labels for varied types of drug products in a global setting required
• 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 preferred
• Familiar with organizing responses to Health Authority requests preferred
• Experience in international import and export permits a plus