Principal Scientist, Global Labeling Regulatory

ImmunityBio•Summit, NJ

19h•Onsite

About The Position

ImmunityBio, Inc. is seeking a Principal Scientist, Global Labeling to be responsible for the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. This expert will work with other cross-functional teams and SMEs to ensure that all labeling for investigational and marketed drugs meet the regulatory requirements of global health authorities. The company is a commercial-stage biotechnology company developing cell and immunotherapy products designed to help strengthen each patient’s natural immune system. They are 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.

Requirements

Bachelor’s degree in life sciences or related field 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 in life sciences or related field with 8+ years’ experience working on clinical and commercial labels for varied types of drug products in a global setting required.
Familiar with organizing responses to Health Authority requests required
Expert in Global Health Authority Regulatory labeling requirements for both clinical and/or 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
Experience working in a complex and matrix environment
Excellent interpersonal skills

Nice To Haves

Experience with Veeva Vault preferred

Responsibilities

Create and execute global labeling strategies from early clinical development through commercialization.
Contribute to writing and maintaining key labeling documents, such as 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.
Create label technical specifications
Creation of labeling related change controls
Review and approve label proofs provided by internal and external labeling teams
Assist with the preparation of responses to Health Authority comments and questions pertaining to labeling issues.
Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Benefits

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