Regulatory Affairs Documentation Specialist

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

Does it excite you to keep regulatory submissions on track for one of the industry's most closely watched obesity programs, and do you have a talent for turning cross‑functional input into submission‑ready documentation? If this sounds like you, and you are ready to take on a broad area of responsibilities across our clinical pipeline, then you could be our new colleague.

Your new position

As our new Regulatory Documentation Specialist, you will support the petrelintide projects, driving the operational delivery of CTA/IND/NDA/MAA/PIP and meeting package submissions. You will be the operational backbone of our submission management process, working closely with RA and cross‑functional colleagues, and external stakeholders to ensure high‑quality, submission‑ready documents. This is a role for someone who thrives on structure, detail, and keeping regulatory activities on track.

We offer exciting responsibilities:

• Drive the planning, coordination and execution of CTA/IND/NDA/MAA/PIP/PSP meeting package submissions in line with regulatory strategy, ensuring timely delivery of high‑quality documents.
• Communicate and 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 ensure archiving of regulatory documents in Veeva RIM.
• Act as subject matter expert for the Clinical Trials Information System (CTIS), representing Regulatory Affairs in internal and external CTIS working groups.

Your profile

You are structured, collaborative and proactive, with a natural ability to keep multiple stakeholders and moving parts aligned toward a shared deadline. You take ownership of your tasks, communicate clearly across functions, and stay calm and organized even when submission timelines are tight.

Relevant experience from the pharmaceutical industry within regulatory affairs/documentation and HA submissions Experience with Veeva RIM and CTIS Strong stakeholder management skills, with experience coordinating cross‑functional and external parties (CROs, publishers) High attention to detail and strong organizational skills to manage multiple submission timelines in parallel Fluency in English, written and spoken

Your new team

You will join RA Clinical Petrelintide with 6 highly skilled Regulatory Affairs colleagues. The department is one of the five departments within Regulatory Affairs & Medical Writing.

Let's bond and be bold

We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture. Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

For further information, please contact Senior Director, Head of RA Clinical Petrelintide, Susanne Lund Olsen, [e-mail].

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late‑stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

Company Overview

Since our founding in 1998, Zealand Pharma has built a core expertise in the discovery, design, and development of therapeutic peptides. This expertise has led to an R&D pipeline of innovative investigational candidates designed to address a broad range of disease areas. We have four therapeutic focus areas: obesity, rare diseases, chronic inflammation, and type 1 diabetes. In obesity, our peptide capabilities place us in a unique position to address a vast global health challenge and positively impact hundreds of millions of lives. Within rare diseases, we have a long‑standing commitment to deliver new treatments to patients living with congenital hyperinsulinism and short bowel syndrome. For chronic inflammatory diseases, we are progressing peptide programs focused on high‑profile targets shown to be difficult to address with small molecules and antibodies. For type 1 diabetes, we aspire to change the management of this disease. Our strategy is to pursue global co‑development and commercialization partnerships that complement and extend our capabilities across the value chain to deliver new peptide therapies to people who need them.