Global Regulatory Submissions Coordinator

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

Job summary

Novo Nordisk A/S in Søborg, Denmark is seeking a Regulatory Professional in Affiliate Coordination & Optimization to plan, coordinate and execute national registration file documentation for global regulatory submissions. You will serve as the central contact for affiliates and HQ stakeholders, managing multiple submissions across overlapping timelines.

The role requires a Master’s degree in life sciences, strong English communication, and proven coordination skills.

Qualifications

• Master's degree in a relevant field such as life science, health science, pharmacy or similar
• Preferably experience from the pharmaceutical industry, regulatory affairs or a related business/process-oriented function, including coordination across functions and documentation handling
• Excellent communication skills in English, both written and verbal, with strong cultural awareness and the ability to influence and align diverse stakeholders in a global environment
• A well-organised and flexible approach, with the ability to prioritise and manage multiple assignments under tight deadlines without losing oversight
• A decisive and positive mindset, comfortable taking charge of deliveries, navigating change and driving progress in complex situations

Responsibilities

• Planning, coordinating and executing national registration file documentation for global regulatory submissions across the Novo Nordisk product portfolio
• Clarifying country-specific documentation needs with affiliates and assessing requirements against local regulations and submission timelines
• Preparing and coordinating additional regulatory documents such as pharmaceutical certificates and statements
• Driving progress with internal and external stakeholders, ensuring alignment and timely delivery across several simultaneous submissions at different stages
• Escalating risks or challenges in due time and proposing solutions based on regulatory requirements
• Contributing to continuous improvement of ACO processes to support fast submissions, approvals and regulatory compliance
• Sharing regulatory and process insights with colleagues and identifying opportunities to simplify and improve ways of working

Skills

Coordination

English proficiency

Organized & flexible

Stakeholder management

Problem solving

Education

Master's degree in life sciences

Job description

Novo Nordisk A/S in Søborg, Denmark is seeking a Regulatory Professional in Affiliate Coordination & Optimization to plan, coordinate and execute national registration file documentation for global regulatory submissions. You will serve as the central contact for affiliates and HQ stakeholders, managing multiple submissions across overlapping timelines.

The role requires a Master’s degree in life sciences, strong English communication, and proven coordination skills.