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Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Associate Director - Global Core Labeling (Regulatory Affairs)


Reference:KS/AYLW-3730022 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Specialist

Associate Director - Global Core Labeling (Regulatory Affairs)

Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them.

They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components. The Associate Director ensures timely delivery of global labeling to our clients affiliates to facilitate simultaneous global submissions. Additionally, the Associate Director leads timely updates and communication of core labeling changes throughout the product lifecyle.

Primary Responsibilities:
Global Labeling Leadership

  • Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions.
  • Implement “Accelerate Reach and Scale” initiatives related to global labeling strategy.
  • Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.
Core Labeling Development and Maintenance
  • Lead the development and maintenance of core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL) that includes Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content].
  • Lead the preparation activities and facilitate approval of core labeling by the Global Product Labeling Committee (GPLC) and Global Labeling Council (GLC).
  • Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.
  • Lead the development and maintenance of clinical trial Instructions for Use
Labeling Process Excellence
  • Optimize core labeling exception process. Manage core labeling exception requests and facilitate approval from leadership.
  • Support periodic labeling assessments to assess compliance of affiliate product information with core labeling.
  • Serve as subject matter expertfor core labeling. Effectively resolve identified gaps and issues and help drive continuous improvement in labeling processes.
  • Anticipate and resolve key technical or operational issues that can impact labeling development and timelines.
  • Develop and present metrics to governance and other forums to monitor and improve the labeling exception process.
Lead/Influence/Partner
  • Exemplify the Team behaviors of Include, Innovate, Accelerate, and Deliver.
  • Model the innovation, leadership behaviors, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
  • Participate in forumsthatshareregulatoryinformationacrossGRA components and other teams and business partners.
  • Partner with Global Regulatory Lead and Device Strategy Lead to support global labeling strategy
  • Ensure timely communication of global labeling to global affiliates.
  • Partner with Labeling Implementation Associates to ensure local labeling aligns with core labeling.

Minimum Qualification Requirements:
  • Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience).
  • Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 2 years.
  • Demonstrated knowledge of the drug development process and regulatory/business strategies
  • Demonstrated ability to assess and manage risk in a highly regulatory environment.
  • Demonstrated ability to lead, influence and partner cross-functionally.
  • Demonstrated strong communication skills: writing, presenting, listening.
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal ss.
  • Demonstrated attention to detail and organizational skills.
  • Ability to learn and use new software/technology.
  • Ability to manage multiple tasks simultaneously.
For further information please contact: Karen Shiel on 087 7452487 or send CV in confidence to [email protected]