Regulatory Submission Professional

Cari; Søborg; Remote; DKK 570,000 - 838,000; Full time

Job summary

Cari is seeking a Regulatory Submission Professional to support clinical trials across the Novo portfolio, ensuring health authorities receive submissions on time and in the right format. You will plan distributions worldwide and contribute to EU CTIS submissions in a flexible setup that adapts to peak periods.

Your work helps keep trial timelines moving and shapes how we work. You will collaborate with CTA Management and the EU Submission Hub, staying updated on regulatory knowledge and

Qualifications

• Master’s degree in life science or a relevant field (MSc).
• At least 2 years of experience in Regulatory Affairs or related area.
• Regulatory knowledge in EU/US/others, lifecycle management and health authority interactions.
• Proficiency in planning, coordination and meeting tight timelines.
• Strong written and spoken English with clear communication.

Responsibilities

• Handle Clinical Trial Application distributions worldwide, coordinating submissions.
• Prepare, manage and submit Clinical Trial Applications in CTIS in line with EU CTR requirements.
• Work across IT platforms like Veeva Vault RIM and Vault Clinical to keep submission information accurate.
• Support process development and collaboration between CTA Management and the EU Submission Hub.
• Stay up to date on regulatory knowledge and share best practices.

Skills

Regulatory planning

Coordination

Project management

Communication

English proficiency

Stakeholder management

Education

Master's degree in life science or relevant field

Tools

CTIS knowledge

Veeva Vault RIM

Vault Clinical

Job description

.Your impact begins here

As Regulatory Submission Professional, you will help clinical trials across the Novo portfolio reach health authorities on time and in the right shape. You will plan and coordinate Clinical Trial Application distributions worldwide and contribute to EU submissions through CTIS, in a newly established setup that adds flexibility during peak periods. Your work keeps trial timelines moving, helps shape how we work and supports the progress that brings new treatments closer to people living with serious chronic diseases.

What you’ll bring

• A master’s degree (MSc) in life science or a relevant field.
• At least 2 years of experience in Regulatory Affairs, Clinical Operations or a closely related area.
• Regulatory knowledge in one or more areas, such as regulatory requirements in the EU, US, China or Japan, early- or late-stage drug development, life cycle management, label or device development, health authority interactions or regulatory intelligence.
• Broader expertise that strengthens submission work, such as project management, R&D value chain and pharma understanding, pharmacovigilance, non-clinical, clinical pharmacology, statistics, patient access or real-world evidence.
• Strong planning, coordination and attention to detail, with the ability to deliver to demanding timelines and adapt as priorities and ways of working change.
• Clear communication and some negotiation skills, with the cultural awareness to build trusted relationships across functions, organisational levels and geographies.
• Proficiency in written and spoken English.

Desirable, but not essential:

Hands-on experience with CTIS (including the Part I and Part II structure), understanding of the EU Clinical Trials Regulation (EU) No 536/2014, experience with Veeva Vault RIM and Vault Clinical, and involvement in process improvement projects.

What you’ll do

• Handle Clinical Trial Application distributions worldwide, coordinating and planning the activities that keep each submission on schedule.
• Prepare, manage and submit Clinical Trial Applications in CTIS in line with EU CTR requirements, in close collaboration with the EU Submission Hub.
• Work across IT platforms such as Veeva Vault RIM and Vault Clinical (COSMOS) to keep submission information accurate and accessible.
• Support and drive process development and optimisation, helping shape the new collaboration model between CTA Management and the EU Submission Hub.
• Stay up to date on regulatory knowledge and share better practice with colleagues.

Who you’ll work with

In Research & Development, colleagues advance scientific ideas towards clinical testing, where collaboration and operational excellence help meet future health needs. You will join CTA Management, a team of 11 colleagues within Submission Management in RQ&C Operations, a global organisation of around 180 professionals across multiple regions. You will report to the Associate Director, CTA Management, and work closely with our sister team, the EU Submission Hub, which has 14 colleagues.

Your work often has global impact. Day to day, you will partner with other parts of Regulatory Affairs, including affiliates, as well as Global Development, Global Drug Discovery (Non-Clinical), Global Safety, CMC Clinical Supply, Product Supply, Device R&D, QA, Global Marketing, Global Legal & Patents and Strategic Pricing & Market Access. Externally, you will support correspondence with health authorities and consultants. Clear plans and honest follow-up help all these partners move together at pace.

What you can expect here

You will join a team that supports one another and works across cultures and time zones. Because the collaboration with the EU Submission Hub is newly established, your ideas can directly shape how submissions are handled. Working with trials across the portfolio and partners across the R&D value chain, you will broaden your regulatory expertise, build new skills on the job and be trusted to own your deliverables.

Salary:

For this role, the Annual Base Salary for employees based in Denmark ranges from 570,200 to 838,100 DKK. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge and relevant experience.

Incentives and Benefits:

The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here

We are an equal opportunities employer and are committed to an inclusive recruitment process and equality of opportunity for all applicants.