About this role

  • Posted on

  • Location

    Brussels

  • Salary

    €50000 - €70000 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Regulatory Affairs Jobs

  • Reference

    BB - 12763.5_1602073208

  • Start date

    ASAP

  • Managing this role

Executive Consultant

Brieuc Baeckeroot

+44 203 8540 263

brieuc.baeckeroot@xplorelifescience.com

Source Group International GmbH, Bosch 106, 6331 Hunenberg, Switzerland

Description

Responsible for a Biologic portfolio, you will take care of the life cycle management.

You will have autonomy with your portfolio. This means that you are responsible for the regulatory strategy, the variations, renewals… Having a strong pipeline in development your portfolio will also grow with new products in the future, new countries.

Joining a global company you will have in the mid/long term the opportunity to evolve within the group on diverse responsibilities.

Your task:

  • Responsible for the regulatory support for the CMC matters for the biologic products during their life cycle management.
  • Therefore you will define, implement, and lead the regulatory strategy for the CMC submission.
  • Provide the information needed by the Health Authorities and bring responses to their questions.

Your experience:

  • 5/7 Years of experience in the Pharmaceutical Industry working mainly on the Module 3.
  • Having experience on a manufacturing site OR in Quality assurance is a strong asset.
  • Capacity to exchange with the health authority regarding the CMC matters with the pre & post-approval product
  • Experience with Biologics products.

Do you think you would be a good fit? Do you want to know more about the role? Do not hesitate to contact me.

Contact:

Feel free to reach me even if the position is not exactly what you are looking for.
Please share it with your network or any person you think you might be interested in.

You can send me your CV, Resume with your contact details through the link OR you can contact me on Linkedin.

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