Regulatory / Senior Regulatory Affairs Manager CMC, Brussels

Reference: OLI110493R3

Expiry Date: 26-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

We have a permanent opportunity for a Senior Regulatory Affairs CMC professional to join a highly successful pharmaceutical company in Brussels.

You will work in an international environment supporting a new MAA planned for 2020 and subsequently move on to supporting post-approval CMC projects.

Our client is a successful pharmaceutical company, R&D driven and with a strong pipeline of new products in development as well as several very successful marketed drugs. This organization excels as a company because of its continual high standards, investing in its people as well as its science, and being able to foster a culture of innovation, collaboration and creativity.

Nature and scope of the role:

  • Support the Regulatory CMC Lead with the preparation and compilation of CMC submission documents for assigned small molecule products
  • Be responsible for regional regulatory expertise and have an input into the development and implementation of global regulatory CMC strategy
  • Responsible for managing the CMC aspects of regional Health Authority interactions.

You will have 4 - 8 years relevant experience in the Regulatory Affairs CMC field and would have successfully authored and contributed to delivering CMC submission documents for development and/or marketed products. Experience of direct communication with Health Authorities on CMC matters is required. 

In return you will:

  • You will work with and be supported by experienced Regulatory CMC leadership where the next step - becoming an Associate Director - will be open to you
  • Flexibility to work from home for 1 or 2 days per week after an induction period
  • Earn a competitive for the industry salary, with a bonus and various company benefits. 

Interested in the above? I look forward to hearing from you!

To Apply!

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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