Principal Scientist, Global Labeling Regulatory

Position Summary

The Principal Scientist, Global Labeling will report to the Director, Global Labeling and 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.

Essential Functions

• 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.
• Create label technical specifications
• Create and manage label change controls
• Review and approve label proofs provided by internal and external labeling teams
• Aid in preparing responses to Health Authority comments and questions pertaining to labeling issues.

Education & Experience

• 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.

Knowledge, Skills & Abilities

• 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

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.
• A Principal Scientist 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.
• They will work closely with scientific colleagues throughout the day, often on a project team basis.