Student Assistant (Regulatory Affairs, Kvistgaard)

Job summary

This position offers hands-on experience in a regulatory department, focusing on regulatory information management tasks. The role involves supporting the regulatory CMC team with documentation and metadata management, ensuring compliance with current naming conventions and operational standards.

Qualifications

• Currently studying pharmaceutical sciences or biotechnology.
• Detail-oriented and proactive with a strong focus on quality and compliance.
• Ability to communicate effectively in English (reading, writing, speaking).

Responsibilities

• Improve retrieval of old records by enhancing metadata in the Veeva RIM system.
• Align information to meet current naming conventions and operational procedures.
• Collaborate closely with the Regulatory CMC team and Regulatory Operations Team.
• Assist with administrative tasks related to regulatory submissions.

Skills

• Strong attention to detail and a collaborative mindset.
• Adaptability and willingness to learn in a dynamic regulatory environment.

Education

Work setup

• Enrollment in a relevant degree program (pharmaceutical sciences or biotechnology).
• On-site position, approximately 15 hours per week with flexibility around exam periods.