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RA Consultant

  • Job type Contract
  • Salary Up to €100 per hour
  • Location Netherlands, Netherlands
  • Sector Regulatory Affairs

For an international pharmaceutical company I'm looking for an innovation maker with in-depth knowledge of Regulatory Affairs and also a broad knowledge of Submission and follow-up of evaluation procedures with health authorities, Coordination and preparation of the Marketing Authorization Application file, CE marking, Promotional material management, Life cycle management, CC, Variations & renewals, Regulatory information management.
Project management and operational support to adapt to evolving regulatory constraints and ensure that compliance requirements are respected and maintained without impacting operations.
Business process expertise: all pharmaceutical forms, clinical trials, medical devices in a Life Sciences environment.

As a consultant you?

  • Provide system assessment, establish roadmaps and give advice on technology choice
  • Perform by a unique end-to-end approach combining technology, usage and verification & validation
  • Be involved in safety, regulatory compliance and data (cyber)security issues
  • Work on Technical documentation (Regulatory)
  • You envision the different Life Sciences sectors combined with expertise of local regulatory environments at international level.
  • Perform permanent regulatory watch and capitalisation of best practices and cross sectorial benchmarks.

What do you bring?

  • Bachelor or University degree in Pharmacy, (Bio)Medical Engineering, Regulatory, or equivalent
  • Experienced in regulatory affairs and project management
  • Perform by a unique end-to-end approach combining technology, usage and verification & validation
  • Be involved in safety, regulatory compliance and data (cyber)security issues
  • Familiar with relevant regulations and standards (eg. GMP, EU MDD, FDA, ISO 13485, IEC 62302)
  • Good knowledge of Big Data and Analytics is an absolute plus
  • Strong verbal and writing skills in Dutch and English

Who are you?

  • You are a team player, enthusiastic, client and goal oriented, ambitious and ready to take on a challenge
  • You can adapt easily in new environments and have developed organizational sensitivity
  • You have a creative mind and like to develop yourself more in skills and knowledge by training and coaching and working on innovative, technically challenging and complex projects
  • You can see the bigger picture, have a strong analytical mind and approach challenges from a practical standpoint
  • You are flexible and can communicate on different levels