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Senior Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Copenhagen, Copenhagen Municipality
  • Salary: Competitive
  • Job reference: 424813/001_1555053189
  • Sector: EPM Scientific, Regulatory
  • Date posted: 12/04/2019

Description:

A world-leading Pharmaceutical manufacturer located in the heart of Copenhagen is looking to expand their Regulatory department in preparation for their new product portfolio being rolled at the end of 2019/start of 2020. The company is currently searching for a Senior Regulatory Affairs Manager CMC.

The company has a headcount of around 42,000 globally with around 20% of it's workforce in R&D showing that they reall value innovation and bringing new products in to the pipeline. This global company is at the forefront of the Pharmaceutical and Combination Products sector, has been for a long time and is on a growth path that will allow them to stay at the top. Over 30 million patients have been treated with this organisation's products.

Responsibilities:

    • Implementing Global Regulatory Strategy in CMC
    • Working cross-functionally with Production, Marketing and R&D to meet global business goals
    • Working with global affiliates
    • Managing a team of at least 5 Regulatory Professionals
    • Working closely with local and global Medical Agencie

Skills and Experience Required

    • Extensive Experience in Regulatory Affairs in CMC
    • Experience working in the Pharmaceutical sector
    • Experience in Biologics preferred
    • Experience working with competent authorities (E.g. Danish Medical Products Agency)

What this Job Offers You

    • To be part of a Global Organisation
    • To join a traditional Danish Culture
    • Variance in Day to Day Responsibilities

How to apply

    • Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact Joshua Greaves on: +44 203 758 8818.
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