Senior Submission Professional

Research Operations & Compliance Måløv, Denmark Are you passionate about regulatory submission, working across areas, and being part of a dynamic department? Your new position As a Regulatory Submission Professional, you will coordinate the preparation of submission-ready nonclinical documentation for clinical trial and marketing authorization applications in the US, EU and other global markets.

Importantly, you will play a central role in the migration of nonclinical documents related to acquisitions driving process improvement initiatives to ensure efficient and compliant integration.

You will use your understanding of submission packages, including study reports and administrative regional documents, to bring together contributions from nonclinical project managers, document owners, Regulatory Affairs and publishing colleagues. Your key responsibilities will include:

• - 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 regions1 …