I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
Connect with me on
R&D Director
Galway
R&D Manager
Galway
R&D Manager
Connaught
CQV Lead
Tipperary
R&D Manager
Connaught
Project Engineer
Republic of Ireland
Senior Quality Engineer-Remote
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
Manager R&D
Connaught
R&D Manager
Galway
Chemical Engineer
Tipperary
Process Engineer
Limerick
Head of R&D
Galway
Senior Recruitment Consultant
Republic of Ireland
R&D Manager
Galway
QA Engineer
Leitrim
Product Lead
Dublin
Biostatistician
Dublin City Centre
Account Manager UK and Ireland
Republic of Ireland
Quality Specialist
Tipperary
R&D Engineer
Galway
Project Engineer
Limerick
Senior Recruitment Consultant
Republic of Ireland
R&D Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Project Manager
Limerick
Project Enginer
Dublin South
R&D Director
Galway
R&D Engineer
Galway
R&D Engineer
Clare
R&D Manager
Connaught
R&D Engineer
Galway
R&D Manager
Galway
R&D Engineer
Dublin
Project Engineer
Tipperary
Medical Device Director
Republic of Ireland
R&D Manager
Connaught
Biostatistician
Dublin City Centre
R&D Engineer
Dublin
R&D Director
Galway
R&D Engineer
Galway
Recruitment Consultant
Republic of Ireland
QA Manager
Canada
C&Q Lead
Tipperary
R&D Engineer
Clare
QA Manager
Canada
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Global Labelling Technical Regulatory Affairs Lead (Associate Director)


Reference:KS/AYLW-373002 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

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.
2. US and Canada Labeling Development and Maintenance
    • 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.
3. Labeling Expertise and Process Excellence
    • 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.
4. Lead/Influence/Partner
    • 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.
Qualifications/Experience:

Education:
    • 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.
Additional Preferences / Other Information:
    • 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 information please contact: Karen Shiel on 087 7452487 or send CV in confidence to [email protected]