regulatory submission project leader | budapest

randstad hungary
job type
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job details

job category
Pharma / Healthcare
job type
reference number
28391 / 29447
randstad hungary
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Pozíció leírása / Job description

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:

  • Managing operational aspects of submission planning for assigned products
  • submission planning
  • document retrieval
  • submission creation and delivery to Health Authorities

Elvárások / Requirements

  • Bachelors 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.

Amit kínálunk / Offer

  • A career path that will allow you to become a Subject Matter Expert
  • The opportunity to work on different 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

Kapcsolattartó / Information

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