Global Labelling Technical Regulatory Affairs Lead (Associate Director)

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.

Their office in Cork consists of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Medical, Clinical Trials, Finance, Information Technology and more.

They provide a premium workspace across our campus in Cork, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking, Inhouse People Development services, Educational Assistance, and wellbeing initiatives that enhance the career experience for their employees.

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 Labeling role in the Global Labeling Department at Cork is to lead the development and maintenance of Core labeling documents and provide oversight of global implementation for drug and combination device products. The Associate Director leads the development of United States (US) and Canada packaging and combination device patient labeling. The Associate Director serves as the primary interface with the Printing Packaging Development (PPD) organization for implementation of US and Canada labeling. They drive consistency in labeling processes and operations.

Role/Responsibilities:

1. Core Labeling Development and Maintenance

• Lead the development and maintenance of Core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content].
• Lead the preparation activities and facilitate approval of Core labeling by the Global Product Labeling Committee for CDS and CDL and Global Labeling Council for CMC CLC.
• Communicate initial and revised Core labeling to global affiliates and provide support and consultation, as necessary.

• Lead the development and maintenance of US and Canada packaging for our clients drug and combination device products.
• Lead the development and maintenance of US and Canada combination product patient labeling [i.e., Instructions for Use (IFU) and Quick Reference Guide (QRG)]. Serve as primary liaison with the Device Delivery & Connected Solutions (DDCS) organization.
• Lead the development and maintenance of Clinical Trial IFUs.
• Demonstrate in-depth understanding of content, format, and s requirements for labeling documents including local regulations, guidance, and trends.
• Conduct data integrity reviews of healthcare provider labeling in partnership with GRA-NA Clinical Regulatory.
• Serve as primary liaison with PPD organization for implementation of US and Canada labeling.
• Serve as primary liaison with DDCS and PPD organizations for development of labeling artwork.
• Communicate initial and revised US and Canada labeling to global affiliates and provide support and consultation, as necessary.
• Lead labeling contributions for periodic reporting (e.g., FDA Annual Report, Periodic Safety Update Report, Periodic Benefit/Risk Evaluation Report, Development Safety Update Report) in collaboration with GRA-NA Clinical Regulatory.
• Coordinate the translation of labeling documents with vendors.

• Provide Regulatory input and guidance on Core labeling and US and Canada labeling specific to packaging and IFUs.
• Manage Core labeling exception requests from affiliates and facilitate approval from leadership.
• Perform periodic labeling assessments to assess compliance of affiliate product information with 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.
• Maintain the end-to-end labeling system for Core, US, and Canada labeling.
• Develop, update, maintain, and archive labeling documents utilizing appropriate tools, systems, and version control.
• Plan, track, and record labeling submission and approval activities using the appropriate tools and systems.

• Exemplify the teams behaviours of Include, Innovate, Accelerate, and Deliver.
• Model the innovation, leadership behaviours, and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Participate in forums that share regulatory information across GRA components and other teams and business partners.
• Collaborate effectively with business partners and stakeholders.

• 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 minimum of 5-8 years.

• Regulatory experience. Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory reform initiatives related to combination products.
• Ability to apply therapeutic expertise.
• Project Management experience.
• Demonstrated ability to lead, influence and partner.
• Demonstrated communication skills: writing, presenting, listening.
• Demonstrated effective teamwork skills; ability to adapt to diverse interpersonal ss and working across geographies.
• Demonstrated attention to detail and organizational skills.
• Ability to learn and use new software/technology.
• Ability to manage strategic and operational tasks.