Regulatory Submissions Specialist: Documentation & Coordination

Zealand Pharma A/S; Denmark; On-site; DKK 550,000 - 850,000; Full time

Job summary

Zealand Pharma A/S is seeking a Regulatory Documentation Specialist to drive the operational delivery of CTA/IND/NDA/MAA/PIP submissions and related documents. You will work closely with RA and cross-functional colleagues, coordinating with CROs and publishers to ensure submission readiness.

You will maintain trackers, handle CTIS activities, and act as a subject-matter expert to keep regulatory activities on track.

Qualifications

• Relevant experience in regulatory affairs/documentation and HA submissions in pharma.
• Experience with Veeva RIM and CTIS.
• Strong stakeholder management skills and ability to coordinate cross-functional/external parties.
• Fluency in English, written and spoken.

Responsibilities

• Plan, coordinate and execute regulatory submission packages (CTA/IND/NDA/MAA/PIP/PSP) on time and to high quality standards.
• Collaborate with RA, CROs, publishers and external vendors to ensure alignment and timely delivery.
• Coordinate HA submissions including Q&A, DSUR, IB and Annual Report, and QC and release submission packages.
• Maintain regulatory trackers/logs (DSUR Compliance Log, IB Tracker, Correspondence/Commitment Log) and archive docs in Veeva RIM.
• Serve as subject-matter expert for CTIS and represent Regulatory Affairs in CTIS groups.

Skills

Stakeholder management

Cross-functional coordination

Attention to detail

Organizational skills

Communication

Fluent English

Tools

Veeva RIM

CTIS

Job description

Zealand Pharma A/S is seeking a Regulatory Documentation Specialist to drive the operational delivery of CTA/IND/NDA/MAA/PIP submissions and related documents. You will work closely with RA and cross-functional colleagues, coordinating with CROs and publishers to ensure submission readiness.

You will maintain trackers, handle CTIS activities, and act as a subject-matter expert to keep regulatory activities on track.