Regulatory Affairs Coordinator

Job summary

The role involves coordinating regulatory affairs tasks across the Nordic markets, specifically Denmark, Sweden, Norway, and Finland. The position is office-based in Copenhagen and requires a structured individual who can manage documentation and ensure timely completion of tasks. Limited travel may be necessary.

Qualifications

• Relevant education in business administration, life sciences, or similar, or equivalent experience in a coordination or administrative role.
• Experience in a regulated industry such as pharmaceuticals, healthcare, or cosmetics is advantageous but not mandatory.
• Prior experience in Regulatory Affairs is a plus but not required.

Responsibilities

• Coordinate marketing authorizations for medicinal products in Nordic markets.
• Manage updates to packaging materials and artwork for compliance.
• Support variation applications and marketing authorization processes, ensuring timely delivery and complete documentation.
• Provide local regulatory support for centrally approved products, tracking actions and maintaining records.
• Facilitate communication with suppliers, regulatory authorities, and internal teams.
• Ensure daily business continuity across QA, RA, and Pharmacovigilance by coordinating activities and addressing issues.
• Maintain documentation and administrative processes within QA/RA/PV, including document control and filing.

Skills

• Strong coordination and communication abilities, with a knack for managing multiple contacts and tasks.
• Highly organized and detail-oriented, with a disciplined approach to documentation.
• Service-minded and solution-oriented, capable of prioritizing tasks under overlapping deadlines.
• Proactive and pragmatic, with a willingness to take ownership of tasks.
• Collaborative and positive, ready to support across functions as needed.

Education

• Relevant educational background or equivalent experience in a coordination role.

Tools

• Familiarity with documentation management systems and regulatory compliance processes is beneficial.