Principal Specialist, Global Labeling Regulatory

Role Summary

The Principal Specialist, Global Labeling Regulatory is responsible for the strategic global development, maintenance, and compliance of product labeling throughout a drug's lifecycle. The role will ensure all labeling for investigational and marketed drugs meet the regulatory requirements of global health authorities. The Principal Specialist will also participate in the development of global CMC regulatory strategy for investigational and marketed products and the preparation of dossiers in Electronic Common Technical Document (eCTD) format. The Principal Specialist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs).

Responsibilities

• Create and execute global labeling strategies from early clinical development through commercialization.
• Contribute to writing and maintaining key labeling documents, such as the Company Core Data Sheet (CCDS), 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.
• Assist with preparation and review Module 2 (QOS) and Module 3 documents in accordance with eCTD guidance and company standards.
• Contribute to the development of global CMC regulatory strategies.
• Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation.
• Assist with the preparation of responses to Health Authority comments and questions pertaining to labeling issues.
• Develop and adhere to Standard Operating Procedures (SOPs) and process improvements as needed.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Qualifications

• Required: Bachelor’s degree with 10+ years’ experience working on clinical and commercial labels for varied types of drug products in a global setting; or
• Required: Master’s degree with 8+ years of experience working on clinical and commercial labels for varied types of drug products in a global setting
• Required: Experience in Global Health Authority Regulatory labeling requirements for both clinical and commercial stage products
• Preferred: Experience in the preparation and submission of CMC modules in eCTD format
• Preferred: Familiar with organizing responses to Health Authority requests
• Preferred: Experience in international import and export permits

Skills

• Expert knowledge in Global Health Authority Regulatory labeling requirements for both clinical and 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
• Excellent interpersonal skills

Education

• Bachelor’s degree with 10+ years’ relevant experience in global labeling (as described above) or
• Master’s degree with 8+ years’ relevant experience in global labeling

Additional Requirements

• On-site work requirement; standard Monday–Friday schedule with possible manager-approved flexibility.
• Role involves desk-based work, long periods of screen time, and close study of scientific and regulatory documents.
• Collaborative work with scientific colleagues on project teams.