Senior Manager Regulatory Affairs CMC, Brussels, work on NBEs

Reference: Oli10481D1

Expiry Date: 04-05-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

Senior Manager Regulatory Affairs CMC, Brussels, work on NBEs

We have a permanent opportunity for a Snr Manager Regulatory Affairs CMC professional to join our client on their exciting journey.

You will work in an international environment supporting a new MAA and subsequently moving on to supporting and leading biological molecules in development.

This role is based in Brussels, Belgium. 

Our client is an international Biopharmaceutical company with several block busters and a strong pipeline of new products in development. This organisation excels as a company because it invests in its people as well as its science, it has being able to foster a culture of innovation, collaboration, creativity and maintain continual high standards.

What will you do?

  • Lead projects as assigned and be responsible for the preparation, authoring and compilation of Regulatory CMC dossier for CTAs and MAAs (IMPDs, INDs, MAAs, BLAs etc.)
  • be responsible for regional regulatory expertise and have an input into the development and implementation of global regulatory CMC strategy
  • Manager the CMC aspects of regional Health Authority interactions.

Who’s right for the job?

You will have 5 plus years relevant experience in the Regulatory Affairs CMC field and would have successfully authored and contributed to delivering CMC submission documents for biological products in development and marketed products. Direct communication experience with Health Authorities on CMC matters is required. Good level of English is a must as this is the business language in this organization.

In return you will:

  • This is an opportunity to become an integral part of an expanding Regulatory Affairs CMC team (these are new roles) in a successful company
  • Work in the Global HQ where most of the team is based and be supported by experienced Regulatory CMC leadership in a growing organization where the next career step will be open for
  • Earn a competitive for the industry salary, with a bonus and other company benefits. Have the flexibility to work from home 2 days per week.

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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