Associate Digital Product Director – Regulatory Data & AI

Cph Ai Hub; København; Remote; DKK 1,500,000 - 2,100,000; Full time

Job summary

Zealand Pharma A/S in Copenhagen invites an Associate Digital Product Director to shape regulatory data and AI-enabled solutions across Regulatory Affairs and Medical Writing. You will own Veeva Vault RIM data and collaborate with DD&T to enable compliant platforms for EMA and FDA submissions.

You will drive roadmaps, define data products, explore AI opportunities and lead cross‑functional, GxP‑validated initiatives with a strong focus on data governance and system evolution.

Qualifications

• Extensive experience in digital product management, business systems or technology transformation.
• Solid understanding of Regulatory Affairs and product development lifecycle (CTAs/INDs, eCTD, submissions).
• Experience with complex business apps, data models, master data and cross-system integrations; hands-on with Veeva Vault RIM; eTMF/Safety Vaults a plus.
• Ability to define product vision, prioritize competing needs and align business, IT, data and external partners around shared outcomes.
• Familiarity with APIs, data pipelines, data lakes, BI tools such as Vault Loader, as well as data governance, data ownership and data product concepts, and an interest in generative AI.
• Proven ability to lead complex initiatives independently, including integrations, release management in GxP environments, adoption and change management.

Responsibilities

• Drive digital product strategy and roadmaps aligned with enterprise data and AI strategy.
• Own the product hierarchy and regulatory master data in Veeva Vault RIM as business data owner.
• Connect regulatory data across Veeva RIM, eTMF and Safety Vaults and make it available to enterprise platforms and data lakes.
• Explore and assess generative AI and intelligent automation; turn opportunities into practical solutions with governance.
• Define and own regulatory data products, APIs, reporting and BI solutions on the enterprise data platform.
• Lead system evolution and cross-functional transformation initiatives, including integrations and release management in GxP environments.

Skills

Digital product management

Business systems

Technology transformation

Regulatory Affairs

Veeva Vault RIM

APIs

Data platforms

Generative AI

Data governance

Leadership

Tools

Vault Loader

Veeva Vault RIM

Job description

Does it excite you to shape digital products and AI-enabled solutions that make regulatory data flow reliably across the enterprise and on to EMA and FDA, and do you have experience with Veeva Vault RIM? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position

As Associate Digital Product Director – Regulatory Data & AI, you will drive the evolution of our digital products, enterprise systems and data capabilities, with a primary focus on Regulatory Affairs and Medical Writing and opportunities across the wider organization. A key responsibility is the continued development of regulatory data capabilities in Veeva Vault RIM and other connected Vaults, ensuring that product hierarchies and master data are structured consistently and flow reliably across systems and to health authorities. You will act as business owner of regulatory data, working in close partnership with Digital, Data & Technology (DD&T’s) Data Analytics & AI Platforms team. As our pipeline advances towards late-stage submissions and our digital transformation accelerates, you will build the foundations for connected, data-driven and increasingly AI-enabled business processes that are built on trusted data and responsible AI practices.

We offer exciting responsibilities:

• Drive digital product strategy and roadmaps aligned with Zealand’s enterprise data and AI strategy, translating business needs into prioritized initiatives that deliver measurable value
• Own the product hierarchy and regulatory master data in Veeva Vault RIM as business data owner, ensuring clear stewardship, accuracy, completeness and consistency across the organization
• Connect business-critical regulatory data across Veeva RIM, eTMF and Safety Vaults and, together with DD&T, make it available to enterprise platforms and data lakes, in alignment with regulatory data standards (IDMP, SPOR, xEVMPD, eCTD v4.0), GxP and data integrity requirements for EMA and FDA
• Explore and assess generative AI, AI agents, intelligent automation and advanced analytics, and turn promising opportunities into practical solutions for Regulatory Affairs and Medical Writing, through governed AI delivery, together with DD&T and business teams
• Define and own regulatory data products, APIs, reporting and business intelligence solutions, built on the shared enterprise data platform with DD&T, that make information more accessible, actionable and reusable across functions
• Lead system evolution and cross-functional transformation initiatives, including those supporting Medical Writing, from evaluating new releases and capabilities to implementation, validation, change management and post-launch optimization

Your profile

You are a digitally minded product professional who combines business understanding, systems thinking and technological curiosity. You understand the importance of regulatory data and the processes it supports, and you look beyond individual systems to see opportunities across the wider digital ecosystem. You work independently, bring structure to complex initiatives and build trusted relationships across business and technology teams. You are comfortable owning data in the business and you are curious about how AI, automation and modern data platforms can transform the way we work, and you help colleagues build confidence in new ways of working.

• Extensive experience in digital product management, business systems or technology transformation, ideally within pharmaceutical, biotech or another regulated industry
• Solid understanding of Regulatory Affairs and the product development lifecycle, including CTAs/INDs, eCTD, submissions and lifecycle management
• Experience with complex business applications, data models, master data and cross-system integrations; hands-on experience with Veeva Vault RIM is important, and experience with eTMF or Safety Vaults is an advantage
• Ability to define product vision, prioritize competing needs and align business, IT, data and external partners around shared outcomes
• Familiarity with APIs, data pipelines, data lakes, business intelligence and tools such as Vault Loader, as well as data governance, data ownership and data product concepts, and an interest in generative AI and intelligent automation
• Proven ability to lead complex initiatives independently, including integrations, release management in GxP-validated environments, adoption and change management

Your new team

You will join Regulatory Operations (RegOps), part of Regulatory Affairs & Medical Writing. RegOps is a team of four and the backbone of our regulatory submissions and systems, responsible for Veeva Vault RIM, submission publishing and the regulatory data that supports our pipeline. The team also supports digital and process initiatives within Medical Writing. You will work closely with Regulatory Affairs, Medical Writing, Clinical, Safety, DD&T, the Data Analytics & AI Platforms team and external partners.

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 Head of Regulatory Operations Kristian Kiilerich:

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.