Regulatory Digital Solutions Lead

Orion Advisor Solutions; Espoo; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Orion Pharma is seeking a Development Manager, Regulatory eTools to lead digital transformation of regulatory operations within the Product Information team in Finland. The role combines Product Information Management and Regulatory Publishing, advancing electronic Product Information (ePI) and eCTD capabilities.

The two-year fixed-term position offers hybrid work with locations in Espoo or Turku. You will collaborate across Orion's international network to implement sustainable digital

Qualifications

• Relevant academic background and/or professional experience in Pharmacy or Life Sciences.
• Interest in product information management and digital regulatory solutions.
• Basic understanding of eCTD structure and regulatory publishing.
• Strong organizational skills and ability to work independently.
• Fluent Finnish and English; Swedish is a plus.
• Experience in pharmaceutical/healthcare industry is advantageous.

Responsibilities

• Participate in the implementation and maintenance of regulatory databases, platforms, and digital solutions.
• Contribute to development, documentation, and training of new processes.
• Create, update, review, and coordinate pharmaceutical Product Information content across product lifecycle.
• Publish regulatory submissions in line with eCTD requirements.
• Monitor evolving regulatory requirements and communicate their impact.
• Drive problem solving and process improvement within system development activities.

Skills

Digitalization

Product Information Management

Regulatory knowledge

Cross-functional collaboration

Communication skills

Education

Pharmacy / Life Sciences background

Tools

eCTD publishing tools

Job description

Orion Pharma is seeking a Development Manager, Regulatory eTools to lead digital transformation of regulatory operations within the Product Information team in Finland. The role combines Product Information Management and Regulatory Publishing, advancing electronic Product Information (ePI) and eCTD capabilities.

The two-year fixed-term position offers hybrid work with locations in Espoo or Turku. You will collaborate across Orion's international network to implement sustainable digital