Regulatory Affairs CMC Senior Manager, Development projects, Brussels

Reference: Oli10486B1

Expiry Date: 04-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

Regulatory Affairs CMC Senior Manager, Development projects, Brussels

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

We are hiring for a Regulatory CMC Senior Manager to join a global pharmaceutical company in Brussels, Belgium, leading submissions in development.

Join our client on their exciting journey. They are an international pharmaceutical company with a strong pipeline and a number of successful drugs on the market. This is an R&D driven organization that is now expanding their Regulatory Affairs CMC team across Europe and the US. We are looking to hire a versatile Regulatory CMC professional for this client, to lead a variety of projects in development.

What would your duties be?

  • The first projects you will work on will be a new MAA for a mAb currently in Phase 3, planned for this or next year and then move on to leading projects in development.
  • You will have an input into the Regulatory CMC strategy. 
  • Writing and reviewing regional CMC submission documents (IMPDs/INDs, MAAs/NDAs).
  • Responsible for Health Authority interactions and for provide regional Regulatory CMC expertise.

The role comes with a competitive salary package and flexible working environment where you can work 1-2 days from home. This is an opportunity to join a successful company that invests in its people as well as its science. The organization nurtures a team culture of mutual respect and support. You will work alongside experienced leaders who will help you along getting to the next level of your career.

Specific skills and competences:

  • 5 years of Regulatory Affairs CMC experience is needed. Experience authoring and reviewing IMPD/INDs as well as MAA/BLAs.
  • Lifecycle management experience filing major Variations, Renewals etc.
  • Experience in direct communication with the Health Authorities is also necessary.
  • We need a good communicator, with demonstrated leadership skills who is also eager to learn and develop.

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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