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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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1905250 Requisition #
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Project Manager, Western Europe, Regulatory Affairs - Immunology

Based in the Maidenhead offices with flexible working options and 15% travel, we will also consider applicants based in other EU countries but this will have increased travel due to being part of the UK team.

Reporting to the Therapy Area Head, Immunology.

Competitive salary, Long Term Incentives, Great working environment, 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.

 

Highlighted responsibilities: 

  • Implement regulatory strategies & deliverables typically for late development and marketed products in the assigned Therapeutic Area for the WE Area (including Israel, Turkey and Switzerland). In alignment with the overarching global regulatory strategy and region specific requirements.
  • May receive delegation to represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met. Duly reports on activities in these teams and alerts his/her management when necessary.
  • Propose a Local Regulatory Strategic Tactical Plan (L-RSTP) in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT).
  • Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).

Qualifications & experience:

  • Previous Pharmaceutical industry experience in Regulatory Affairs or R&D is a must.

  • Demonstrable experience of working with European regulatory agencies.

  • Experience working effectively across cultures and in complex matrixed environment.

  • Strong project manager, excellent organisational skills and solution driven style.

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