Regional Submission Planner

ES-13462

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Location:

Budapest

The Regulatory Submissions Planner will:

  • Support the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.
  • Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.
  • Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholders

Your main functions would be:

  • Manage Operations aspects of submission planning for assigned products;
  • submission planning
  • document retrieval
  • submission creation and delivery to Health Authorities

Required for this role:

  • Bachelor’s degree in a Life Science related discipline.
  • High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
  • Affinity to work with complex IT systems
  • English language knowledge, intermediate or above
  • At least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.

What our partner company can offer:

  • A career path that will allow you to become a Subject Matter Expert
  • The opportunity to work on different Pharmacovigilance/Regulatory processes across different projects
  • Trainings on various competencies and skills
  • Language courses and training
  • On-site relax & gym rooms
  • Volunteering, sport and employee events

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