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Manager, Regulatory Global Labeling

United States, San Rafael 108000.00 - 162000.00 USD / Year · Job Posted January 06, 2026
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Job Description

This position will be responsible for leading the development, review, and management of US, EU, and International labeling for a product in development and commercial products. The incumbent will be responsible for assessing and managing labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages. The Reg Global Labeling Manager (GLM) will ensure the appropriate labeling strategies are communicated to project teams; compliant with core labeling and local regulations; ensure the labeling is accurate and of the highest quality; and support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status.

Job Responsibility

  • Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
  • Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
  • Ensure appropriate labeling strategies are communicated to project teams
  • Ensure labeling is compliant with core labeling and local regulations
  • Ensure labeling is accurate and of the highest quality
  • Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
  • Lead the assigned product labeling teams (PLTs) and support labeling positions
  • Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
  • Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
  • Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content
  • Facilitate the review and approval process within the product labeling teams
  • Manage approved labels in a label management database/corporate system
  • Maintain knowledge of current rules and regulations governing global labeling activities
  • Receive and collate labeling text from labeling team members and manage labeling content and revision control
  • Review and approve artwork and change control related to labeling activities
  • Support launch and/or release of revised labeling into production
  • Prepare labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS
  • Represent REG GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs)
  • Participate on Product Core Teams and present strategic global labeling issues to Regulatory Management
  • Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices
  • Document control and distribution of product labels
  • Project management role of logistical activities and delivering labeling documents within agreed timeframes
  • Create and maintain regulatory compliant, competitive and up to date Company Core Data Sheets
  • Prepare and manage International labeling including tracking differences in local labels to the CCDS
  • Manage translations and address discrepancies with local partners and linguistic experts
  • Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes in local product information
  • Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings
  • Assess country-specific deviations from the CCDS
  • Provide RA input to Periodic Safety Update Report (PSUR) and Annual Reports
  • Support the development of artwork and approve new or revised labeling to be implemented into production
  • Approve all change requests for revised labeling
  • Provide Supply Chain and QA guidance on labeling implementation requirements
  • Support first launch into new markets
  • Contribute to global labeling management and continuous improvement initiatives
  • Review and comment on emerging internal and external guidelines and regulations
  • Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes

Requirements

  • 4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
  • 2+ years in Regulatory Affairs
  • Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
  • US and/or EU Labeling experience minimally required and core labeling experience highly desired
  • Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
  • Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
  • Experience with E2E global labeling processes and management of Company Core Data Sheets
  • Experience in review process, standards, and industry best practice pertaining to labeling
  • Strong scientific background and/or experience
  • Working knowledge of medical terminology and drug safety
  • Proven project management, leading teams from multiple functional areas
  • Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labeling
  • Experienced processing and assessing translations of labeling a plus
  • Excellent verbal and written communication skills
  • strong technical writing and presentation skills
  • Must be able to work as a team member and independently
  • Strong attention to details required and high-quality work
  • Fluency in English as business language, additional languages advantageous
  • Ability to travel (up to 15%) for industry conferences or other business meetings
  • Flexibility to work occasional nights and weekends as determined by critical Regulatory deadlines
  • Minimum requirements BS or MS with requisite experience and demonstrated capability
  • Science or medical background desirable

Nice to have

International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable

What we offer

  • Discretionary annual bonus
  • Discretionary stock-based long-term incentives
  • Paid time off
  • Company-sponsored medical, dental, vision, and life insurance plans

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