Regulatory Submissions Lead — Nonclinical & Global

Novo Nordisk A/S

Måløv

On-site

DKK 651,000 - 957,000

Full time

6 days ago

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Job summary

Novo Nordisk A/S seeks a Regulatory Submission Professional to coordinate preparation of nonclinical submission packages for clinical trials and marketing applications in the US, EU and global markets. You will drive acquisition migrations and ensure compliant integration, collaborating with project managers, Regulatory Affairs and publishing colleagues.

The role requires a strong background in submission packages, GLP-knowledge and a proactive, independent approach to quality and timelines,

Qualifications

Bachelor’s or Master’s degree in pharmacy, science or related field.
5+ years’ experience with regulatory submissions in pharma or similar.
Experience with Document Management Systems (Veeva Vault) and MS 365 (Word/Excel).
Knowledge of EMA, FDA, ICH and other electronic documentation requirements.
Experience with process development and optimization.

Responsibilities

Timely preparing accurate and high-quality nonclinical submission packages with contributors.
Support integrations of acquisitions by migrating regulatory nonclinical documents and data.
Coordinate with Regulatory Affairs and publishing to align requirements, timelines and deliverables across regions.
Drive process improvement to enhance automation, efficiency, quality and compliance.