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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Regulatory Affairs
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1902692 Requisition #
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Therapeutic Area Head (Western Europe), Regulatory, Oncology

Based in our Maidenhead offices with up to 30% travel.

Reporting to the Head of Regulatory Affairs, Western Europe.
Competitive salary, long term incentives, car allowance, bonus and comprehensive benefits package.

 

The company:

AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children.

 

The role:

The core purpose of this role is to support the AbbVie regulatory mission, which is, with a focus on our patients, to design and deliver optimized global regulatory strategies for Western Europe that align with AbbVie’s business strategy. This is an exciting opportunity to head up the Oncology Regulatory Affairs team (consisting of 8 direct reports), in a European Centre of Excellence, in a company with a leading edge pipeline in the oncology space. The role presents an opportunity for ‘cross-cultural’ leadership, interacting regularly with the Global Regulatory function and Area Commercial teams.

 

Highlighted Responsibilities:

  • Leads the assigned Western Europe Regulatory Affairs (WE RA) Oncology team in the preparation and maintenance of regulatory product strategies for development of marketed products submitted to the European Medicines Agency and national competent authorities in AbbVie’s Western Europe region and regulatory agencies in Turkey, Switzerland and Israel.
  • Ensures inclusion of strategic messaging in the content of WE RA dossiers.
  • Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for the oncology portfolio.
  • Builds, coaches and manages high performing, qualified teams, implementing the AbbVie RA vision, and truly living the AbbVie ‘Ways we Work’.
  • Leads the team by ensuring that company policies and procedures for regulatory record keeping are followed, and may contribute to the development and implementation policies and procedures within the RA department.
  • Maintains an active awareness of EU legislation and its impact on AbbVie business and R&D programmes. Develops and executes strategies to respond to those.


Qualifications & experience:

  • Extensive pharmaceutical industry experience in European Regulatory Affairs (including Israel, Turkey and Switzerland)

  • Previous Oncology experience is preferred.

  • Experience working effectively across cultures

  • At ease in operating in a matrix environment.

  • Strong dynamic presence with experience of leading teams.

 



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