Associate Director, Labeling Operations

• 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.

Qualifications

• 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.

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