Regulatory Filing Consultant | 4 months
SIRE
Zuid-Holland, The Netherlands
2 dagen geleden

The company

Our client is a professional organisation, based in Zuid-Holland Netherlands. The mission of this company is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented.

In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases.

Trying to achieve the best possible results for their health.

Improving the access to medicines, making the best available treatment at an affordable price, working in this entrepreneurial company will enrich your career!

Role description

They are looking for a specialist in Regulatory Filing with a good knowledge and understanding of viral safety. The Analytical Development department is responsible for developing methods that are required for analysis of vaccines for human use.

This includes testing for identity, quantity, potency, purity and contamination.

In particular : the safety of foreign substances.

You will be responsible for the extraneous agents safety of products developed by the company. You will translate company agents safety strategy into position papers and / or briefing books for health authority's scientific advice.

Demonstrating flawless documentation, effective communication with varied level of the organization and a strong sense of responsibility and quality are necessary to succeed within this position.

Responsibilities

  • Responsible for the extraneous agents safety of products developed by the company
  • Translating company agents safety strategies into position papers and / or briefing books for health authority's scientific advice
  • Communicating with different levels of the organization
  • Working together within a multidisciplinary team
  • Requirements

  • Ph.D. degree with publications
  • Excellent writing skills
  • Specialization in Regulatory Affairs for a minimum of 8 years
  • Knowledge of viral safety (In vitro and In vivo virus testing, human virus testing)
  • Experienced within biopharmaceutical manufacturing
  • Excellent writing skills
  • Other information

    This position is for maximum of 32 hours a week.

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.

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