Expiry Date: 10-11-2020
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Regulatory / Senior Manager Regulatory Affairs CMC - Biologic products Development role based in Brussels
Location: Brussels, Belgium
We have a Senior Manager Regulatory CMC role – working on NBEs. This is a permanent role based in Brussels, Belgium.
Our client is an R&D driven Biopharmaceutical Company with an impressive pipeline of biologic products coming up in development, as well as a strong portfolio of filed products. They are a global firm that has over the years pushed the boundaries of what is possible in order to transform patient’s lives. They have done this successfully by investing heavily every year in cutting-edge scientific research and producing successful drugs that have made a real difference to people suffering with severe diseases all over the world.
This role will give you the opportunity to become an integral part of a growing Regulatory team contributing to the development of successful Regulatory CMC strategies, serve as the Product Lead for assigned products and also provide regulatory leadership when needed. Working in the company’s global HQ you will be supported by talented and experienced Regulatory leaders where the career path to become an Associate Director will be open for the right person.
This role is for an experienced Manager with a proven track record of successful authoring of the CMC sections of MAAs for NBEs. Our client has several new products coming up in development in their pipeline. You will be responsible for providing expert support, author and review submission documents as well as be responsible for developing and implementing regulatory CMC strategies for assigned products in development in accordance with global and company guidance’s.
Flexible working hours are available as well as working from home 2 days per week. The salary comes with a competitive salary and a bonus structure.
To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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