Would you like to work as as Consultant Regulatory Affairs and do you have direct and significant regulatory experience with vaccines? One of our clients is looking for you! Read this vacancy.

Functie

The primary responsibility is to support the regulatory activities related to vaccines in all global markets. Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to vaccines. Additional responsibilities include:

  • Contribute to the preparation and editing of clinical trial and marketing applications including post-approval changes;
  • Correspondence and direct interaction with Health Authorities;
  • Development of product-specific regulatory strategy documents;
  • Technical review and approval of master protocols, reports and other source documents;
  • And other related duties as assigned.

Functie eisen

  • Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs, and post-approval submissions for vaccines highly preferred;
  • Strong knowledge of EU and FDA regulations is required, experience with other markets is added value;
  • Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred;
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required;
  • Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.

Aanbod

This is a responsible job with good employment conditions.

Sollicitatie Procedure

Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: joost@xdes.nl Kenmerk: 10663.

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Solliciteer

Vacature: Consultant Regulatory Affairs

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