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Associate Director, Labeling Operations

Avanir Pharmaceuticals, Inc
United States, New Jersey, Princeton
August 03, 2023
Leads Global Labeling Compliance oversight for all aspects of the end-to-end labeling process and systems, including distribution, tracking, metrics and reporting. Leads Global Labeling inspection / audit activities. Acts as operational expert and lead for the Global Labeling tracking in RIMs or other systems. Determines, evaluates and investigates quality events, conducts root cause analyses and develops CAPA plans, where needed. Serves as Global Regulatory Affairs contact for PSMF activities. Demonstrates understanding of labeling requirements, regulations and guidance in support of labeling strategies worldwide. Support of Labeling Operations activities, where needed.
  • Lead oversight of global distribution, tracking, and reporting of approved labeling and labeling updates.
  • Lead the monitoring and reporting of compliance metrics for end-to-end labeling processes.
  • Act as operational expert and lead for the Global Labeling tracking in RIMs or new technology / systems under evaluation
  • Lead labeling inspection / audit activities, including CAPA development and implementation.
  • Serve as Global Regulatory Affairs contact for PSMF activities.
  • Lead the tracking of all labeling changes, implementation and deviations for assigned regions.
  • Evaluate and monitor compliance metrics for end-to-end labeling process.
  • Develop and report GL metrics and dashboards to support GL compliance oversight.
  • Determine, evaluate and investigate quality events, conduct root cause analyses and develop CAPA plans.
  • Collaborate with global colleagues, affiliates and alliance partners, as needed, for effective and efficient global distribution and tracking of labeling updates for products.
  • Collaborate for development, review and maintenance of labeling agreements with alliance partners and company subsidiaries.
  • Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements.
  • Ensure content reviews and QC checks are performed for consistency between internal labeling documents (i.e., Core Data Sheet and other core labeling documents) and all local/regional labeling and supportive documents.
  • Manage and maintain labeling documents in document management systems; Manage label review and approval.
  • Contribute to the continuous improvement of the end-to-end labeling policies, processes, quality, and system tools.
  • Ensure development and maintenance of templates, collaboration features and system upgrades.
  • Act as GL subject matter expert when a new labeling technology and/or system is being evaluated.
  • Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
  • Support of Labeling Operations activities, where needed.
  • Responsibilities may include the managing of direct/indirect reports to assist with compliance tracking.
  • May be assigned additional responsibilities, as deemed necessary.

Knowledge and skills

  • Solid understanding and interpretation of US labeling regulatory requirements, preferred.
  • Solid understanding of pharmaceutical regulatory affairs and willingness to learn global labeling regulatory requirements and industry practice.
  • Solid understanding of requirements for tracking of labeling updates
  • Solid understanding of the structure of product labeling
  • Strong written and oral communication and organizational skills
  • Strong attention to detail
  • Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications
  • Ability to generate problem solving innovative solutions
  • Ability to recognize and escalate issues
  • The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams.


  • MS/BS in life sciences or another scientific field.
  • 6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development
  • Global Labeling tracking experience (concepts & systems)
  • Electronic document management systems use and / or electronic submission experience.

#MZ1 #LI-remote #labeling

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