Global Regulatory Submissions Coordinator

Novo Nordisk A/S; Søborg; Remote; DKK 570,000 - 838,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Submission Professional to help clinical trials reach health authorities on time. You will plan and coordinate CTA distributions worldwide and contribute to EU submissions through CTIS, in a setup that adds flexibility during peak periods.

You should bring a MSc in life science and at least 2 years in Regulatory Affairs or related areas, with strong English and excellent coordination skills to keep timelines moving and ensure high-quality

Qualifications

• Master’s degree in life science or a related field.
• At least 2 years in Regulatory Affairs or Clinical Operations.
• Experience with EU/US/China/Japan regulatory requirements.
• Strong planning and stakeholder management and ability to meet tight timelines.

Responsibilities

• Coordinate Clinical Trial Application distributions worldwide.
• Prepare and submit Clinical Trial Applications in CTIS per EU CTR.
• Collaborate across IT platforms to ensure submission information is accurate.
• Support process development and optimization between CTA Management and EU Submission Hub.

Skills

Regulatory Affairs

Clinical Operations

English Proficiency

Project Management

Regulatory Intelligence

Cross-functional Collaboration

Education

MSc in life science or related field

Tools

CTIS

Veeva Vault RIM

Vault Clinical (COSMOS)

Job description

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Submission Professional to help clinical trials reach health authorities on time. You will plan and coordinate CTA distributions worldwide and contribute to EU submissions through CTIS, in a setup that adds flexibility during peak periods.

You should bring a MSc in life science and at least 2 years in Regulatory Affairs or related areas, with strong English and excellent coordination skills to keep timelines moving and ensure high-quality