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Herakles Pharma

RA Consultant

Functiegroep: Regulatory Affairs
Locatie:Leiden
Procedure: Detachering
Vacature ID:#763
Publicatiedatum:12-03-2019

RA Consultant

De organisatie

Janssen Research & Development, a member of Johnson & Johnson’s Family of Companies, is recruiting for a consultant Global Regulatory Affairs – CMC with a focus on Vaccines.

Janssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

De functie

Responsibilities & Accountabilities for the function as a RA Consultant:

The Consultant, Global Regulatory Affairs – CMC will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to support the regulatory activities related to vaccines in Europe and US, and specifically to support the preparation of a MAA and BLA. The Consultant will support CMC Teams and provide direction on the interpretation and application of CMC regulations and guidances related to vaccines. Additional responsibilities include: contribute to the preparation and editing of clinical trial applications that include vaccines

Het profiel

Qualifications, Education, Skills & Experience for the function as a RA Consultant:

  • MSc degree in biological, pharmaceutical, or chemical sciences;
  • 5-8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience;
  • At least 5 years of experience in CMC-Regulatory Affairs is required;
  • Working permit for EU and residency in the Netherlands mandatory;
  • Knowledge of vaccines required;
  • Strong knowledge of EU and FDA regulations is required;
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required;
  • Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred. – Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.

Het aanbod

The maximum hourly rate is € 100,- (all-in, incl. travel).

Inlichtingen bij

For more information about the RA Consultant please contact Rob Helmich at rob@heraklespharma.nl or +31 6 538 538 92.

Meer informatie
Rob Helmich Director Recruitment & Account Management rob@heraklespharma.nl +31 6 53853892