Global Regulatory Affairs CMC Manager, Biologics, NBEs - Brussels, Belgium

Reference: Oli10481BA1

Expiry Date: 31-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

Global Regulatory Affairs CMC Manager, Biologics, NBEs - Brussels, Belgium

We have a new, permanent role for a Manager or Snr Manager Regulatory Affairs CMC Biologics, based in Brussels, Belgium. This is with a successful biotechnology company.

 Location: Brussels, Belgium

With over 20% of profits reinvested in R&D, a busy pipeline of early and late stage development projects, several business acquisitions recently as well as billions of euros planned in investments, this is a company at a pivotal stage of its history. Our client is expanding and hiring in order to support 4-5 major submissions planned in the next few years. They require a RA Manager to work on a variety of projects covering the full lifecycle, from early and late stage development through initial MAA/BLA to lifecycle management and regulatory CMC strategy.

You would consider this role if you want to:

  • Work in a company that is growing, financially healthy and has a successful track record in developing and marketing novel molecules.
  • Want to work in an international, matrix environment with seasoned GRLs who have great deal of experience developing people and will challenge and support you along the way.
  • Want to gain M3 build experience, including authoring and re-authoring of sections for QOS and M3 for the first/initial MAA/NDA/BLAs as well as IMPD/INDs.
  • Want to learn how to develop Regulatory CMC strategy in time.
  • Want to work in global team where you can gain or consolidate your EU and US experience.

Who’s right for the job?

  • My client is offering Manager or Senior Manager grading for this role, so you may be a professional with 2-4 or 4-7 years of Regulatory CMC Biologics experience. You may have analytical development, process development or bio manufacturing experience previously and now want to consolidate and develop your regulatory career.
  • You would have worked in a Regulatory CMC Bio function, authoring and re-authoring Module 3 for mAbs, other proteins, ATMPs etc.
  • You might be an RA CMC individual who has early to late stage development experience authoring IMPDs, INDs, Scientific Advice preparation etc.
  • You would have experience managing CMC aspects of Health Authority questions.

Package & Bens

My client offers a competitive salary, including a bonus, and incentives plan. The company is willing to consider individuals that want to work from home for 2 days a week post-Covid and is one of the first of our clients to recruit and on-board digitally at the start of the pandemic.

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.

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 SARS-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.

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