Regulatory Submissions Specialist: CTIS, INDs & NDAs

zealandpharma; Søborg; On-site; DKK 520,000 - 780,000; Full time

Job summary

Zealand Pharma A/S seeks a Regulatory Documentation Specialist to drive submission operations across CTA/IND/MAA/PIP, ensuring timely, high-quality documents. The role interfaces with RA and cross-functional teams to maintain trackers and CTIS processes.

You will coordinate with CROs, publishers and external partners, manage DSUR IB QA activities and support archiving in Veeva RIM. Fluency in English and meticulous attention to detail are essential.

Qualifications

• Experience with regulatory submissions (CTA/IND/MAA) and HA communications.
• Proven ability to coordinate cross-functional teams and external partners.

Responsibilities

• Drive planning and execution of regulatory submissions (CTA/IND/MAA/PIP/PSP).
• Coordinate with CROs, publishers and external vendors.
• Maintain regulatory trackers and ensure archiving in Veeva RIM.
• Act as SME for CTIS and participate in related working groups.

Skills

Regulatory affairs

Documentation management

CTIS

Veeva RIM

Stakeholder mgmt

Education

Pharmaceutical degree

Tools

Veeva RIM

Job description

Zealand Pharma A/S seeks a Regulatory Documentation Specialist to drive submission operations across CTA/IND/MAA/PIP, ensuring timely, high-quality documents. The role interfaces with RA and cross-functional teams to maintain trackers and CTIS processes.

You will coordinate with CROs, publishers and external partners, manage DSUR IB QA activities and support archiving in Veeva RIM. Fluency in English and meticulous attention to detail are essential.