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ImmunityBio, Inc. · 14 hours ago

Principal Specialist, Global Labeling Regulatory

Summit, NJ

Full-time

Onsite

Lead/Staff

$168K/yr - $185K/yr

8+ years exp

ImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative cell and immunotherapy products. The Principal Specialist, Global Labeling Regulatory is responsible for the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle, ensuring compliance with regulatory requirements and interacting with cross-functional teams.

Health CareHealth DiagnosticsTherapeutics

Responsibilities

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

Qualification

Global Health Authority RegulationsLabeling Strategy DevelopmentECTD Submission PreparationElectronic Document ManagementInterpersonal SkillsOrganizational SkillsAttention to DetailWritten CommunicationOral Communication

Required

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

Expert knowledge in Global Health Authority Regulatory labeling requirements for both clinical and commercial stage products

Proficient in Electronic Document Management Systems

Ability to work with firm deadlines and adapt quickly to changing requirements and priorities

Strong organizational skills, written and oral communication skills, and attention to detail

Keen awareness of cultural sensitivities

Excellent interpersonal skills