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  • Location

    Amsterdam

  • Job title:

    Regulatory Affairs

  • Sector:

  • Job ref:

    48720

  • Start Date:

    2022-09-01

About the company:

Our client is a giant in the clinical and medical field, operating globally for more than 60 years in the field. It specializes in research and implement new techniques to fight the world's greatest health threats.

About the role:

The role focuses on operating the artwork management process daily.

Responsibilities:

  • Ensure product labeling, achieving deadlines, target dates and internal and external communication are executed properly, and coordinate artwork projects with guidance from labelling department
  • Coordination and implementation of new and revised product labeling in line with regulatory product files.
  • Collecting all necessary information for the preparation of new product labeling, such as technical specifications, design specifications, registration requirements and texts.
  • Responsible for proper phasing of the modified materials and control of phasing out of the existing packaging materials.
  • Responsible for correct/complete intake of the documents and procedure that trigger initiation of introductions / changes
  • Is Subject Matter Expert for more than one topic within the artwork management discipline (e.g. pack site, global topic on downstream artwork management processing, work process, business expertise)

Requirements:

  • Bachelor degree is required or proven related working experience
  • Preferably gained work experience in Regulatory, QA ,RA
  • Preferably experience working with an artwork/document management system
  • Preferably experience with GMP guidelines within the pharmaceutical industry.
  • Preferably have experience of minimally 3 year in RA and RA legislation
  • Fluent English