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Associate Director, Global Labeling

Reference Number: 2775
Location: NJ

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

The Associate Director, Global Labeling will provide leadership to the Global Regulatory Affairs Labeling Group, within Commercial Regulatory Affairs, by managing labeling operations and actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development.  This person 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 Core Data Sheets (CCDSs), US Package Inserts (PIs), Summary of Product Characteristics (SmPCs), and Emerging Market (EM) 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 EM label 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 and USPIs and provides oversight of this process for SmPCs and EM labels.
  • 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 the Company’s electronic document management system for all global labels at various stages of development, review, and approval.
  • Manages labeling development, review, and approval 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 up to date information regarding initiatives by FDA, EMA, and other applicable regulatory authorities relating to labeling.
  • 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 of a BS degree or higher in life sciences.
  • 7-10 years in Regulatory, R&D or related area, 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 is desirable.
  • 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 2775. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.