Regulatory Submission Professional

Novo Nordisk A/S; Søborg; Remote; DKK 570,000 - 838,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Submission Professional to help clinical trials reach health authorities on time. You will plan and coordinate CTA distributions worldwide and contribute to EU submissions through CTIS, in a setup that adds flexibility during peak periods.

You should bring a MSc in life science and at least 2 years in Regulatory Affairs or related areas, with strong English and excellent coordination skills to keep timelines moving and ensure high-quality

Qualifications

• Master’s degree in life science or a related field.
• At least 2 years in Regulatory Affairs or Clinical Operations.
• Experience with EU/US/China/Japan regulatory requirements.
• Strong planning and stakeholder management and ability to meet tight timelines.

Responsibilities

• Coordinate Clinical Trial Application distributions worldwide.
• Prepare and submit Clinical Trial Applications in CTIS per EU CTR.
• Collaborate across IT platforms to ensure submission information is accurate.
• Support process development and optimization between CTA Management and EU Submission Hub.

Skills

Regulatory Affairs

Clinical Operations

English Proficiency

Project Management

Regulatory Intelligence

Cross-functional Collaboration

Education

MSc in life science or related field

Tools

CTIS

Veeva Vault RIM

Vault Clinical (COSMOS)

Job description

Your impact begins here

Location: Søborg, Capital Region of Denmark, DK

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

You know your way around regulatory or clinical work and enjoy keeping many moving parts on track. We are looking for:

• 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

Your focus will be in CTA Management, supporting clinical trials across the entire portfolio, while also contributing to EU submissions alongside our sister team.

• 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.

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