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

Reference: Oli10481BA1R

Expiry Date: 15-12-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


Apply for position

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.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.