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Director, Global Labeling

Reference Number: 2849
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for a Director, Global Labeling.

The Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Affairs (GRA).  This position will manage labeling operations and actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development.  Reporting to the Head of Global Regulatory Operations, this person will serve as an expert on regulations governing labeling of pharmaceutical products globally.  The Director will manage Labeling Managers and Associates and serve as the global regulatory labeling representative on relevant project teams to provide strategic input into the development and approval of all company product Company Core Data Sheets (CCDSs), US Package Inserts (PIs), Summary of Product Characteristics (SmPCs) and Growth Market (GM) labels.

Major tasks and responsibilities will include:

  • Leads cross-functional teams in the timely development of content for a new or revised CCDS, USPI, SmPC and Growth Market labels for assigned products in various therapeutic areas.
  • Acts as a liaison between co-promote partners and company stakeholders in the labeling process.
  • Leads the development, review, approval, and implementation process for all CCDSs, USPIs, SmPCs and Growth Market labels.
  • Accountability for establishing and maintaining processes and standards for global labeling.
  • Supervises Labeling Managers and Associates to effectively operationalize labeling activities across all products.
  • Develops and mentors direct reports on both operational and strategic aspects of labeling.
  • Maintains a centralized labeling repository within electronic document management system for all global labels at various stages of development, review, and approval.
  • Manages labeling development, reviews and approves workflows and tracks the timely and consistent implementation of safety changes in local labels.
  • Provides labeling support for US and EU Packaging Engineering functions for artwork control and approval, Annual Reports, Changes Being Effected (CBEs), Prior Approval Supplements (PASs).
  • Ensures consistency of labeling across product lines and compliance with company policies and procedures and applicable regulatory authority directives and regulations.
  • Analyzes competitor labeling and ensures company products have most competitive labeling.
  • Maintains expertise regarding key labeling requirements worldwide and stays current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities.
  • Represents Global Labeling group on Regulatory Sub-teams and other project teams, communicates key strategy and ensures labeling positions are appropriately represented.

We seek candidates with the following qualifications:

  • Minimum BS degree or higher in life sciences.
  • 12 years in Regulatory, R&D or related area, with at least 4 years of experience in labeling or equivalent experience within the pharmaceutical industry.
  • Demonstrate a solid working knowledge of drug development process and FDA labeling; knowledge of and experience with EU, Asia and Emerging Market labeling desirable.
  • Experience in both local and global regulatory labeling environments.
  • Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
  • Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral), attention to detail, and ability to work under tight timelines.


Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2849. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.