ImmunityBio
Director, Global Labeling Regulatory
Summit, NJ · Director
Sponsorship not specifiedDetected 31 days ago
GMPFDA RegulatoryLeadershipCommunicationProblem SolvingMentoringOrganizational SkillsRegulatory Affairs
About the role
- The Director, Global Labeling Regulatory will orchestrate the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle.
- 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
- Oversee or advise in negotiations with Regulatory Agencies regarding the content of product labels
Responsibilities
- 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.
- 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.
- 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)
- 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
- 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
- Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities
Requirements
- Bachelor's Degree in life sciences or technical discipline with 14+ years of relevant progressive experience required
- Master's Degree in life sciences or technical discipline with 12+ years of relevant progressive experience required
Nice to have
- 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
Skills
- Leadership ability with demonstrated problem solving and decision-making skills
- Knowledge, Skills, & Abilities
Compensation
- The annual base pay range for this position is below.
Benefits
- Direct the preparation of responses to Health Authority comments and questions pertaining to labeling issues
Visa & Work Authorization
- 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
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