Regulatory Affairs Specialist (Budapest)

Regulatory Affairs Specialist (Budapest)
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Humán Centrum Kft.

Regulatory Affairs Specialist


All over the world, the company colleagues are working together to positively impact health for everyone, everywhere. Each position at the company touches and contributes to the success of their business and their world. That's why, as one of the global leaders in the biopharmaceutical industry, the company is committed to seeking out inspired new talents who share their core values and mission of making the world a healthier place.


  • Preparation of Marketing Authorization (MA) applications, renewals, variations and related activities: Collate, coordinate, create the necessary technical data to support the submission of new MA applications, renewals and variations for the assigned products
  • Support the European wide application process for the assigned products, clarifying the requirements and ensuring local needs are met
  • Inform the relevant internal stakeholders about the regulatory authority’s approval of changes to the packaging component(s) for the assigned products
  • Handling with all relevant global databases and systems and other applications
  • Monitor the progress of applications against the set timelines
  • Provide support for local inspections as defined by the Regulatory Inspection Site Action Plan
  • Professional interaction and expertise communication with external (Health Authority inquiries) and internal stakeholders


  • University degree in life science/medical science/pharmaceutical or chemistry
  • Experience in Regulatory in minimum 2 years
  • Understanding National and EU key Directives and Regulations
  • Organizational skills to manage different tasks in a timely and thorough manner
  • Diplomatic in communication with internal and external customers
  • Able to work effectively in a regional team and collaborate
  • Computer literate (MsOffice, Excel, etc)
  • Fluent English and Hungarian language communication verbal and written

What we offer

  • Competitive salaries
  • Customized benefits packages
  • Supportive and diverse culture

Munkavégzés helye

  • Budapest XII.

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