Global Regulatory Submissions Specialist

Novo Nordisk; Gladsaxe Kommune; Vor Ort; DKK 570.000 - 838.000; Vollzeit

Zusammenfassung

Novo Nordisk seeks a Regulatory Submission Professional to help clinical trials reach health authorities on time and in the right shape. You will plan and coordinate Clinical Trial Application distributions worldwide and contribute to EU submissions through CTIS, in a newly established setup that adds flexibility during peak periods.

Your work keeps trial timelines moving, helps shape how we work and supports the progress that brings new treatments closer to people living with serious chronic

Qualifikationen

• Master's degree in life science or relevant field.
• At least 2 years of experience in Regulatory Affairs or related areas.
• Knowledge of EU/US/Japan regulatory requirements and health authority interactions.
• Experience with CTIS and EU CTR concepts is a plus.

Aufgaben

• Handle Clinical Trial Application distributions worldwide and plan submissions.
• Prepare and submit CTIS-compliant applications with EU Submission Hub.
• Work across Veeva Vault RIM and Vault Clinical to maintain data accuracy.
• Support process development and collaboration between CTA Management and EU Submission Hub.
• Stay updated on regulatory knowledge and share best practices.

Kenntnisse

Strong planning and coordination

Clear communication

Negotiation skills

Cultural awareness

English proficiency

Ausbildung

Master's degree (MSc) in life science

Tools

Veeva Vault RIM

Vault Clinical (COSMOS)

Jobbeschreibung

Novo Nordisk seeks a Regulatory Submission Professional to help clinical trials reach health authorities on time and in the right shape. You will plan and coordinate Clinical Trial Application distributions worldwide and contribute to EU submissions through CTIS, in a newly established setup that adds flexibility during peak periods.

Your work keeps trial timelines moving, helps shape how we work and supports the progress that brings new treatments closer to people living with serious chronic