Associate Director Global Regulatory Affairs CMC, Biologics, NBEs – Brussels, Belgium

Reference: OLI10571B

Expiry Date: 06-11-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

Associate Director Global Regulatory Affairs CMC Biologics in mid to late stage of development (mAbs), file a new MAA/BLA with a growing R&D based company.

Consolidate your EU and US Regulatory CMC experience. File initial MAA/BLAs.

This is an opportunity to join an already successful biopharmaceutical company at a pivotal stage of their history. With a diverse and busy pipeline, several major MAA/BLAs planned in the coming years, 2 business acquisitions recently adding to the pipeline, as well as billions of euros planned in reinvestments in R&D, this company offers great career opportunities.

Why consider this role?

We are seeking an individual who can thrive in this environment and wants to work in a company which is growing and has a successful track record in developing and registering molecules.

  • You will be leading the Global Regulatory CMC strategy for biologics (mAbs) in mid and late stage of development. The company has 4-5 NMEs to file in the next few years, so even if the clinical data does not pan out, you will have other NMEs to move to quickly.
  • You will have worked in Regulatory CMC Biologicals for 4-5 years already, have solid experience re-authoring expert reports into the dossier’s quality modules. You may also have previous experience in analytical development, process development or bio manufacturing.
  • You will work in the global HQ of this company where the core leadership team is based, giving you high visibility as well as an opportunity to be involved in key strategic decision making. You will work under a GRL who has a great deal of experience and knows how to support, mentor and grow people in this organization.

This is an opportunity for you to consolidate and develop your Regulatory CMC career is a merit-based company where empowerment and promotions are encouraged

Package & Benefits

This company offers a competitive salary, including a bonus and a share plan as well as other benefits. Relocation will be offered to those who want to move to Belgium from elsewhere in the EU. The company is willing to consider individuals that want to work from home for 2 days per week post Covid-19 (currently you can work from home).

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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