Regulatory Consultant
SIRE
Zuid-Holland, The Netherlands
6 dagen geleden

The company

Our client is a professional organisation, based in Zuid-Holland Netherlands. Their mission 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, starting in this entrepreneurial company will enrich your career!

Role description

This department is responsible for the development of methods that are required for analysis of vaccines for human use. Analysis includes testing for identity, quantity, potency, purity and contamination.

In particular; extraneous agents safety.

Responsibilities

You will be responsible for the molecular and bioassays and / or analytical methods for products developed by this company.

In particular; responsibility for ensuring method validations meeting the regulatory expectations and for translating testing strategies into company position papers and / or briefing books for health authority's scientific advice.

Demonstrating flawless documentation, effective communication with varied levels of the organization with a strong sense of responsibility and a passion for quality are key competences for this position.

Requirements

  • PhD. degree with publications and excellent writing skills
  • 5 years' of experience with regulatory filing for bio-pharmaceuticals
  • Knowledge of method development and validation
  • Bio-pharmaceutical manufacturing
  • Excellent writing skills
  • Other information

    Do you enjoy working in a multidisciplinary team?

    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.

    Solliciteren
    Bij de favorieten invoegen
    Verwijder van favorieten
    Solliciteren
    Mijn E-mail
    Door op "voortzetten" te klikken, gaat u ermee akkoord dat neuvoo uw persoonlijke gegevens verzamelt en verwerkt die u in dit formulier hebt verstrekt, om een ​​neuvoo-account te maken en u te abonneren op onze e-mailwaarschuwingen, in overeenstemming met ons Privacybeleid . U kunt uw toestemming te allen tijde intrekken door te volgen deze stappen .
    voortzetten
    Aanvraagformulier