Senior Process and Compliance Manager

Zealand Pharma A/S; Denmark; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Zealand Pharma A/S is seeking a regulatory/compliance professional to lead inspection readiness activities and support regulatory inspections. You will develop and manage processes, provide GCP guidance, and ensure compliant record management across the organization.

The role requires a Life Sciences degree, strong knowledge of ICH-GCP/FDA/EMA, and experience in clinical trial record management; CTIS & ClinicalTrials.gov submission experience is a plus.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• Solid experience in a regulatory/compliance role within biotech/pharma.
• Deep knowledge of clinical trial regulations (ICH-GCP, FDA, EMA).
• Experience with trial record management and document control.
• Familiarity with CTIS & ClinicalTrials.gov submissions is a plus.

Responsibilities

• Lead inspection readiness activities and support regulatory inspections and audits.
• Develop, implement, and manage inspection readiness processes (SOPs, guides, checklists).
• Provide GCP advice and assist teams in responding to observations.
• Maintain regulatory record management in line with standards.
• Oversee development and maintenance of SOPs and compliance docs.
• Collaborate with cross-functional teams to address compliance issues.

Skills

Regulatory knowledge

CTIS familiarity

Clinical trial record management

Analytical thinking

Communication skills

Project management

Cross-functional collaboration

Detail orientation

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Your new position

We offer exciting responsibilities:

• Lead Clinical Trial inspection readiness activities and be an active contributor during regulatory inspections and audits
• Contribute to the development, implementation, and management of inspection readiness processes (SOPs, guides, checklists) while actively working with teams and providing internal support to ensure adherence to regulatory requirements
• Provide GCP advice and support teams in responding to inspection and audit observations
• Enhance and maintain record management adhering to regulatory and company standards
• Oversee the development and maintenance of Standard Operating Procedures (SOPs) and other compliance documentation
• Collaborate with cross-functional teams to address and resolve compliance-related issues efficiently

Your profile

• You thrive in a role where structure meets curiosity, and you're motivated by turning complex regulatory requirements into clear, practical processes.
• Minimum bachelor’s degree in Life Sciences or a related field; advanced degree preferred
• Solid experience from a similar role within the biotech or pharmaceutical industry
• In-depth knowledge of clinical trial regulations and guidelines, including ICH-GCP, FDA, and EMA requirements
• Experience in clinical trial record management
• Preferable experience in managing CTIS & ClinicalTrials.gov submissions, including disclosure of clinical trial information
• Strong analytical and problem-solving skills, with a strategic mindset
• Excellent communication and interpersonal skills, with the ability to foster collaboration across departments
• Detail-oriented with robust project management capabilities.

Your new team

Clinical Oversight and Compliance is a newly established department, anchored in Clinical Operations and growing to support all of Development. Our team of 8 specializes in processes, compliance, quality risk management, sponsor oversight, and clinical technologies and as we expand, so does our impact across the organization. We work as one team, with an informal atmosphere built on knowledge sharing and a shared drive for excellence.

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.

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

For further information, please contact Head of Clinical Oversight and Compliance, Helle Maach-Møller on [e-mail]

From August 3rd to August 14th, 2026, please contact Head of Clinical Operations Tove Kristensen Stryhn on [e-mail]

About Zealand Pharma

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 datadriven 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.

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.