Regulatory Affairs Specialist

Job summary

This role involves managing marketing authorizations and lifecycle activities for a defined portfolio within a Nordic affiliate, requiring collaboration across various teams. The position demands a strong understanding of Nordic and European regulations, as well as the ability to interpret and apply these regulations effectively.

Qualifications

• University degree in a relevant field such as pharmaceuticals or life sciences.
• 1-5 years of experience in regulatory affairs preferred, but newly graduated candidates may also be considered.
• Proactive team player with systematic approach to regulatory processes.
• Strong communication skills in Danish, Swedish, or Norwegian and English.

Responsibilities

• Oversee lifecycle management activities for assigned products.
• Ensure regulatory compliance for marketing authorizations, including quality documentation and safety updates.
• Respond to health authority requests and provide approved texts for implementation.
• Collaborate closely with Supply Chain, Planning, QA/QC, and commercial teams.
• Act as a regulatory expert, guiding on national and EU legislation.
• Manage regulatory handling of change controls and deviations in validated IT systems.

Skills

• Strong communication skills, both written and verbal.
• Technical proficiency with Electronic Document Management Systems (EDMS) and Regulatory Information Management Systems (RIMS).

Education

• University degree in a relevant field.

Tools

• Experience with IT systems related to regulatory affairs.