CMC Regulatory Affairs Consultant

  • Randstad
  • 5000.00 - 6000.00
  • 32 hours
  • Master degree

Client

Our client is a leading project management and engineering company for industry around the world.

Client

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence.

They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

Requirements

  • Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs.
  • Experience wih 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.
  • Must be able to manage and motivate people within a matrix team environment.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • 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.
  • 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.

TAGCLOUD

regulatoryaffairs
#RA
#pharma
#CMC
#vaccines
#FDA
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1073)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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