Regulatory eTools Development Manager — Hybrid (Finland)

Orion Corporation

Espoo

Hybrid

EUR 90,000 - 120,000

Full time

9 days ago

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Job summary

Orion Pharma Headquarters in Finland seeks a Development Manager, Regulatory eTools, to lead the digital transformation of regulatory operations. The role spans Product Information Management and Regulatory Publishing, advancing Orion’s ePI and eCTD capabilities within a global regulatory network.

You will work with internal and external stakeholders to implement and continuously develop new solutions, in a hybrid Espoo or Turku setting.

Qualifications

  • Relevant academic background in Pharmacy, Life Sciences, Humanities, or related fields.
  • Interest in Product Information Management, structured product data and digital regulatory solutions.
  • Basic understanding of eCTD structure and regulatory publishing.
  • Strong organizational skills, initiative, and ability to prioritise and work independently.
  • Fluent Finnish and English language skills; Swedish a significant advantage.
  • Experience in pharmaceutical/healthcare industry is advantageous.

Responsibilities

  • Participating in the implementation and maintenance of regulatory process databases, platforms, and digital solutions.
  • Contributing to the development, documentation, and training of new processes.
  • Creating, updating, reviewing, and coordinating pharmaceutical Product Information content throughout the product lifecycle in collaboration with Orion's international network.
  • Publishing regulatory submissions in accordance with eCTD requirements.
  • Monitoring evolving regulatory requirements and communicating their impact.
  • Driving problem solving, process improvement, and system development activities.

Skills

Regulatory publishing
Product Information Management
eCTD knowledge
Strong communication
Digital transformation

Education

Pharmacy or Life Sciences background

Job description

Orion Pharma Headquarters in Finland seeks a Development Manager, Regulatory eTools, to lead the digital transformation of regulatory operations. The role spans Product Information Management and Regulatory Publishing, advancing Orion’s ePI and eCTD capabilities within a global regulatory network.

You will work with internal and external stakeholders to implement and continuously develop new solutions, in a hybrid Espoo or Turku setting.

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