Director, Global Labeling Regulatory
ImmunityBio•Summit, NJ
•Onsite
About The Position
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.
Requirements
- 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
- 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
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
