Regulatory Submissions & Documentation Lead

Zealand Pharma; Søborg; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

Zealand Pharma is seeking a Regulatory Documentation Specialist to drive submission-ready documents for CTA/IND/NDA/MAA/PIP across the obesity program. You will coordinate with RA and cross-functional colleagues and external partners to ensure timely, compliant submissions.

You will maintain regulatory trackers in Veeva RIM, act as CTIS SME, and keep submission timelines tight with a structured, detail-oriented approach.

Qualifications

• Experience in pharmaceutical regulatory affairs/documentation and HA submissions.
• Experience with Veeva RIM and CTIS.
• Strong stakeholder management and ability to coordinate cross-functional and external parties (CROs, publishers).

Responsibilities

• Drive planning, coordination and execution of submission packages (CTA/IND/NDA/MAA/PIP) ensuring timely delivery of high-quality documents.
• Coordinate with assigned CROs and external vendors, including publishers.
• Coordinate HA submissions including Q&A, DSUR, IB and Annual Report, and QC and release submission packages.
• Maintain regulatory trackers and logs (DSUR Compliance Log, IB Tracker, Correspondence and Commitment Log) and archiving in Veeva RIM.

Skills

Veeva RIM

CTIS

Stakeholder management

Attention to detail

Organizational skills

English fluency

Tools

Veeva RIM

CTIS

Job description

Zealand Pharma is seeking a Regulatory Documentation Specialist to drive submission-ready documents for CTA/IND/NDA/MAA/PIP across the obesity program. You will coordinate with RA and cross-functional colleagues and external partners to ensure timely, compliant submissions.

You will maintain regulatory trackers in Veeva RIM, act as CTIS SME, and keep submission timelines tight with a structured, detail-oriented approach.