Regulatory Manager – Global Labelling Strategist

Regulatory Manager – Global Labelling Strategist

AbbVie

Maidenhead, Solna, Paris, Budapest, Warsaw or Mannheim

Role Objective

As the Regulatory Manager, you will oversee the tasks to develop and maintain the end-to-end product labeling including ensuring implementation to European Union regulatory labeling strategy, documentation for both marketed products and products in development.

Representing the EU team for content at Labeling Sub Teams, as well as, contributing to operational delivery of packaging artwork, implementation and working collaboratively with stakeholders throughout the EU.

Key Responsibilities

  • Contribute to early-stage product development, providing advice on EU labeling requirements and drafting labeling text and pack layout
  • Responsible for ensuring compliance with all labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labelling for European guideline
  • Review materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and review, for quality assurance
  • Provide analysis on competitor labeling for in class/region
  • Lead product timelines for submission and implementation of label changes, provide information for artwork briefs and production whilst presenting updates to key stakeholders
  • Collaborate with product owners, Brand managers and supply chain functions throughout the end-to-end process
  • Lead project work transforming labelling improvements, compliance and systems
  • Support inspection readiness activities and Label reviews

Qualifications

  • Bachelor degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject. Advanced degree preferred
  • Experienced Regulatory specialist, labeling or equivalent experience within the pharmaceutical industry, European experience required
  • Working knowledge of the drug development process with EU/CP experience
  • Demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills
  • Competent knowledge of and demonstrated ability to apply EU regulatory guidelines pertaining to product labeling

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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