Senior Manager, Global Regulatory Compliance

7 days ago

Cork, Cork, Ireland beBeeGlobal Full time €60,000 - €80,000
Key Job Responsibilities

The role of Associate Director, Global Regulatory Affairs (GRA) is to lead the development and maintenance of global labeling. This involves leading the creation and upkeep of all core labeling documents related to drug, device, CMC, and carton/container components.

Primary Accountabilities
  • Provide strategic leadership for the development of a global labeling strategy that enables simultaneous submissions worldwide.
  • Implement initiatives under the 'Accelerate Reach and Scale' program aligned with the global labeling strategy.
  • Represent GRA globally for assigned products in interactions with 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].
  • Coordinate 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.
Optimizing Labeling Processes
  • Enhance the core labeling exception process to optimize efficiency. Manage core labeling exception requests and facilitate approval from senior leadership.
  • Support regular assessments to evaluate compliance of affiliate product information with core labeling.
  • Serve as a subject matter expert for core labeling, effectively resolving identified gaps and issues while driving continuous improvement in labeling processes.
  • Anticipate and resolve key technical or operational issues impacting labeling development and timelines.
  • Develop and present metrics to governance forums and other stakeholders to monitor and improve the labeling exception process.
Leadership Influence Partnership
  • Exemplify team behaviors including Include, Innovate, Accelerate, and Deliver.
  • Model innovation, leadership, and regulatory excellence attributes described in Global Regulatory Affairs white papers.
  • Participate in forums sharing regulatory information across GRA 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.
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 situations.
  • Demonstrated attention to detail and organizational skills.
  • Ability to learn and use new software/technology.
  • Ability to manage multiple tasks simultaneously.

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