Global Regulatory Submissions Specialist

Cari; Søborg; Remote; DKK 570,000 - 838,000; Full time

Job summary

Cari is seeking a Regulatory Submission Professional to support clinical trials across the Novo portfolio, ensuring health authorities receive submissions on time and in the right format. You will plan distributions worldwide and contribute to EU CTIS submissions in a flexible setup that adapts to peak periods.

Your work helps keep trial timelines moving and shapes how we work. You will collaborate with CTA Management and the EU Submission Hub, staying updated on regulatory knowledge and

Qualifications

• Master’s degree in life science or a relevant field (MSc).
• At least 2 years of experience in Regulatory Affairs or related area.
• Regulatory knowledge in EU/US/others, lifecycle management and health authority interactions.
• Proficiency in planning, coordination and meeting tight timelines.
• Strong written and spoken English with clear communication.

Responsibilities

• Handle Clinical Trial Application distributions worldwide, coordinating submissions.
• Prepare, manage and submit Clinical Trial Applications in CTIS in line with EU CTR requirements.
• Work across IT platforms like Veeva Vault RIM and Vault Clinical to keep submission information accurate.
• Support process development and collaboration between CTA Management and the EU Submission Hub.
• Stay up to date on regulatory knowledge and share best practices.

Skills

Regulatory planning

Coordination

Project management

Communication

English proficiency

Stakeholder management

Education

Master's degree in life science or relevant field

Tools

CTIS knowledge

Veeva Vault RIM

Vault Clinical

Job description

Cari is seeking a Regulatory Submission Professional to support clinical trials across the Novo portfolio, ensuring health authorities receive submissions on time and in the right format. You will plan distributions worldwide and contribute to EU CTIS submissions in a flexible setup that adapts to peak periods.

Your work helps keep trial timelines moving and shapes how we work. You will collaborate with CTA Management and the EU Submission Hub, staying updated on regulatory knowledge and