Global Labeling Specialist

1 day ago

Cork, Cork, Ireland beBeeLabeling Full time €80,000 - €120,000
Global Labeling Expert

We are seeking an experienced professional to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.

As a key member of our team, you will be responsible for ensuring timely delivery of global labeling to our clients' affiliates to facilitate simultaneous global submissions.

Key Responsibilities:
  • Develop and maintain global labeling strategy to facilitate global simultaneous submissions.
  • Prepare 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.
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.
What We Offer:
  • Opportunity to work with a global healthcare leader.
  • Chance to develop and implement global labeling strategy.
  • Collaborative and dynamic work environment.
Preferred Qualifications:
  • Master's degree in a relevant field.
  • Additional certifications in regulatory affairs or drug development.

The ideal candidate will have strong leadership skills, excellent communication skills, and the ability to adapt to diverse interpersonal styles. Ability to learn and use new software/technology. Ability to manage multiple tasks simultaneously.

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