Regulatory Subject Matter Expert

Regulatory, törzskönyvezés, drug safety, customer service

Your new company

We are looking for a Regulatory Subject Matter Expert colleague for our multinational partner developing software for the pharmaceutical industry.

Your new role

  • Work with product owners/customers to understand product background and business requirements
  • Analyze requirements and impact of various scenarios, generate use cases, activity diagrams along with detailed functional specifications document or User Stories for assigned functionality
  • Prepare high quality documents with attention to detail and adhering to Best Practices
  • Work with Engineering team to ensure they understand all aspects of the requirements to implement the configurations and features in the application
  • Test the application before releasing to the customer
  • Work with the internal teams to ensure corresponding test cases are reviewed before development is completed
  • Track regulatory updates from different Health Authorities and inform the customers
  • Provide Trainings and Conduct workshops
  • Answer queries related to business processes
  • The role will be part of ensuring the adherence to Quality Policy and its continual improvement.
  • Good understanding of Drug Safety and Regulatory requirements

What you need to succeed

  • Degree in Life Sciences
  • 3 years’ experience in Regulatory
  • IT skills
  • Good communication skills
  • Very strong English skills (daily work language)

What can you expect from our partner

  • Multinational working environment
  • A rapidly growing organization, that is still flexible and open to ideas
  • Competitive salary & benefits package
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Type de contrat
Secteur d'activité
Life Sciences


Parlez à Fekete Nikolett, en charge de cette offre, située à Budapest
Budapest, Szabadság tér 7, Bank Center

Téléphone: +36707965528

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