About this role

  • Posted on

  • Location

    Switzerland

  • Salary

    £124933.50 - £158249.10 per annum

  • Type

    Permanent

  • Division

    regulatory-affairs-jobs

  • Reference

    BB - 14585.1_1605093037

  • 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

Being part of the registration of a new product is always something special. This a great satisfaction for the company, the patient, and every individual who worked on the development to give the patients a better life.

This is the project you will be part of, taking part in the phase III to submit the drug and obtain the MAA. The Biotech is working on new applications and new development to build their pipeline.
You will take part in a company that will grow, that will allow you to grow in the future.

Your tasks:

  • Work with the Head of Regulatory to define the strategy in order to implement it
  • Prepare the document for the MAA/NDA
  • Be the point of contact with the health authorities (EMA/FDA…)
  • Leading and coordinating the submission activities: CTA, IND, PIP…

Your profile:

  • 10-15 years of experience in Pharmaceutical experience in Regulatory Affairs.
  • Experience with the regulatory activities from the development (CTA) to the registration.
  • Ability to work independently to lead the new drug registration
  • Experience with the EMA & FDA

Want to know more about it? Just be in touch for other opportunities, 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 in the link or by phone: +44 20 3854 0263

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