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Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Associate / Sr Associate (Regulatory Labelling)

Reference:KS/AAPA-204282 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

Associate / Sr Associate - Regulatory Labelling

Our client is a global healthcare leader. Their employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. They are looking for people who are determined to make life better for people around the world. For more than 140 years, they have worked tirelessly to discover medicines that make life better.

They are currently seeking a Labelling Associate / Senior Labeling Associate who will join an established 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 leads the development of United States (US) and Canada packaging and combination device patient labelling. The Associate serves as the primary interface with the Printing Packaging Development (PPD) organization for implementation of US and Canada labeling. The Associate drives consistency in labeling processes and operations.

They offer a premium workspace across their campus in Little Island, 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 are just some of the holistic benefits that enhance the career experience for our colleagues.

Role/ Responsibilities:
1. Core Labeling Development and Maintenance

  • Lead the development and maintenance of Core labelling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labelling Content].
  • Lead the preparation activities and facilitate approval of Core labelling by the Global Product Labeling Committee for CDS and CDL and Global Labelling Council for CMC CLC.
  • Communicate initial and revised Core labelling to global affiliates and provide support and consultation, as necessary.
2. US and Canada Labeling Development and Maintenance
  • Lead the development and maintenance of US and Canada packaging for drug and combination device products.
  • Lead the development and maintenance of US and Canada combination product patient labelling [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.
3. Labelling Expertise and Process Excellence
  • Provide Regulatory input and guidance on Core labeling and US and Canada labelling 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.
4. 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 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)essential
  • Knowledge of the drug development process essential
  • 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.

For further details please contact:

Karen Shiel on 087 7452487 or send CV to [email protected]