Regulatory affairs specialist (marketing authorization)

Törzskönyvezés, beadás, megújítás, variáció, OGYÉI, forgalomba hozatali engedély

Your new company

We are looking for a regulatory affairs specialist colleague for our multinational pharmaceutical partner.

Your new role

  • Collate, coordinate and, where required, create the necessary technical data to support the submission of new Marketing Authorization applications, renewals and variations for the assigned products in accordance with the local legislation.
  • Support the European wide application process for the assigned products, clarifying the requirements and ensuring local needs are met.
  • Inform the relevant internal stakeholders, according to global and local policies and procedures, about the regulatory authority’s approval of changes to the packaging component(s) for the assigned products to ensure their timely and accurate implementation.
  • Link with the Product Quality Manager for timely implementation of the approved labelling-associated artworks.
  • Handling with all relevant global databases and systems and other applications, as appropriate.
  • Keep updated the local registration tracking of all new/ongoing applications, renewals and variations for the assigned products, and corresponding related databases/systems.
  • Provide accurate, consistent, timely and balanced responses to the Regulatory inquiries on the assigned products raised by relevant internal stakeholders.
  • Upon request of the local Product Quality Manager, play an active role in product quality issues actions in order to minimise the impact on business.
  • Provide support for all audits under Medical Director / Platform Head (Regulatory/Safety) Accountability, including audit corrective and preventive action plans (CAPAs).

What you need to succeed

  • Life science graduate
  • 2+ years Regulatory Experience with marketing authorizations, preferably from an innovative company
  • High level of proficiency in both local and English (written and spoken).
  • Proven ability to consistently deliver to time, cost and quality standards.
  • Understanding of National, EU and ICH directives and regulations.

What can you expect from our partner

  • competitive salary and package
  • multinational, innovative company
  • flexible working hours, currently 100% home office and possibility to work mostly from home in the long run as well, if desired

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

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Job Type
Home office / later partly Budapest
Life Sciences

Talk to a consultant

Talk to Altmann Vivien, the specialist consultant managing this position, located in Budapest
Budapest, Szabadság tér 7, Bank Center

Telephone: 36703802102

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