Regulatory Metadata Coordinator

ES-13461

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Location:

Budapest

How will you make an impact?

  • To assist the Publishing & Regulatory Data Entry Manager in providing Global Submission view and strategy Worldwide, in line with Regulatory Strategic Planning.
  • To ensure that metadata submitted to the Health Authorities (HA) and coming from HA are accurate and that Ipsen Regulatory tracking system is aligned
  • To assess Submission strategy impact on Regulatory Tracking System and ensure that Regulatory Tracking System is appropriately maintained.
  • To oversight Service provider(s) for the Centralized Data Entry and HA document upload activities
  • Promotes/Communicates on Regulatory Data process/timeline with RA community, and contributes to the planning of the regulatory submission.
  • Ensures that accurate and up-to-date regulatory information on products, under development, approved and marketed, worldwide is available to all stake-holders.
  • Maintains a continuous flow of information to and from Publishing, GRA, LRAs and Regulatory Operations teams in particular with regards to tracking.

Requirements:

  • Strong analytical and problem-solving capability with attention to detail
  • Strong written and oral communication skills
  • Must exhibit excellent interpersonal, collaborative and team spirit mindset, good communication and follow-up skills
  • Good judgment and decision-making skills
  • Good negotiating and influencing skills
  • Excellent planning, coordination and Project Management skills
  • Willingness to work in a fast-paced environment with stringent timelines
  • Experience in continuous improvement projects and quality management

Advantages:

  • Bachelor Degree in Lifesciences/Pharmacy preferred
  • Up to 2 to 4 years of experience in Regulatory affairs and submission, with Corporate experience

What does our partner offer?

  • A career path that will allow you to become a Subject Matter Expert
  • A great diversity of cultures
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events
  • Get trained on various competencies and skills

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