Director, Global Labeling Regulatory

Position Summary

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.

Essential Functions

• 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

Education & Experience

• 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

Knowledge, Skills, & Abilities

• 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

Working Environment / Physical Environment

• This position works on site in Summit, NJ.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• This position may need to sit for long periods of time and use various computer programs.
• This desk-based role involves the close study of scientific and regulatory documents.
• This position will work closely with scientific colleagues throughout the day, often on a project team basis.
• This position may also need to travel to meet with Regulatory Agencies, attend conferences, or visit manufacturing sites.