Global Regulatory Submissions Specialist

Novo Nordisk; Måløv; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk in Måløv is seeking a Regulatory Submission Professional to coordinate nonclinical documentation for clinical trials and marketing applications in the US, EU, and global markets. You will also drive migration of nonclinical documents during acquisitions, coordinating with Regulatory Affairs and publishing teams across regions.

You will join a small Nonclinical Submission Support Team within ROC, contributing to timely, compliant submissions while enabling scientific innovation and

Qualifications

• Bachelor’s or Master’s degree in pharmacy, science or another relevant field.
• An advanced degree is an advantage.
• At least 5 years of experience with regulatory submissions in the pharmaceutical industry or a comparable environment.
• Experience with global regulatory requirements (EMA, FDA, ICH) and electronic documentation.

Responsibilities

• Timely preparing accurate and high-quality nonclinical submission packages in close collaboration with Nonclinical Project Managers and other contributors.
• Supporting integrations of acquisitions by streamlining processes and coordinating the migration of regulatory nonclinical documents and data into the appropriate systems.
• Coordinating with Regulatory Affairs and global publishing colleagues to align requirements, timelines and deliverables across regions.
• Drive process improvement and optimisation initiatives to enhance automation, efficiency, quality, and compliance.

Skills

Regulatory submissions experience

Veeva Vault

MS Word

MS Excel

Regulatory guidelines (EMA/FDA/ICH)

Process development

Stakeholder management

English proficiency

Document migration

GLP knowledge

Education

Bachelor’s or Master’s degree in pharmacy, science or related field

Tools

Veeva Vault

Microsoft Word

Microsoft Excel

Job description

Novo Nordisk in Måløv is seeking a Regulatory Submission Professional to coordinate nonclinical documentation for clinical trials and marketing applications in the US, EU, and global markets. You will also drive migration of nonclinical documents during acquisitions, coordinating with Regulatory Affairs and publishing teams across regions.

You will join a small Nonclinical Submission Support Team within ROC, contributing to timely, compliant submissions while enabling scientific innovation and