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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Regulatory Manager, Oncology

Primary Maidenhead, United Kingdom Req ID 2212839 Category Regulatory Affairs Division AbbVie

Regulatory Manager, Oncology

  • Hybrid working; Offices Maidenhead, Berkshire
  • Working on innovative new products and lifecycle maintenance
  • Strong career development structure

Job Overview

As a Regulatory Manager at AbbVie, you will be overseeing the lifecycle activities within the Oncology therapeutic area for centralized Europe.  Liaising with our local affiliate and global Regulatory teams to coordinate tasks, to implement strategy and interact with EMA (European Medicines Agency).  As part of a region, you will have the opportunity to develop your skills and career, learning from a diverse team and progress into leadership roles or gain more knowledge in other therapeutic areas.

Key Responsibilities

  • Implement regulatory strategies across Europe, coordinate with global regulatory teams
  • Operate within the scope of European Union and Turkey, Israel, Switzerland and UK to act as the primary interface to and from the regulatory teams in the affiliates and global teams
  • Connect with local health authorities, primarily EMA on license applications within your assigned area of Oncology
  • Uphold an active awareness of EU legislation and assess its impact on AbbVie business
  • Identifies resource needs and tasks within business priorities
  • Lead on projects to continuously improve our performance, improve best practice on processing information

  • Solid understanding of EMA requirements, including previous experience working to these requirements
  • Good understanding of the drug development process in Europe
  • We work in a matrix environment, internationally with stakeholders internally and externally
  • Be proactive in communicating, able to connect within the Area Brand Teams
  • Solution focused
  • Autonomous and able to ask for support, when required
Travel: No
Job Type: Experienced
Schedule: Full-time

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