Senior Regulatory Affairs Professional

Novo Nordisk

. Develop and execute regulatory activities supporting global drug development and lifecycle management .

Posted 10/13/2026full-timeSøborg • DenmarkSenior💰 DKK 651,000 - DKK 956,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory activities for global drug development, including submission strategies, regulatory intelligence, and Health Authority interactions. Proficient in managing complex deliverables and providing guidance to stakeholders while ensuring compliance with regulatory requirements.

Highest-signal resume keywords

Regulatory SubmissionsHealth Authority InteractionsRegulatory IntelligenceDrug DevelopmentLifecycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory IntelligenceDrug DevelopmentLifecycle ManagementLabellingClinical Trial ApplicationsMarketing Authorisation ApplicationsDocument CreationRegulatory GuidancePharmacovigilance

Soft Skills

Strong Written CommunicationStrong Spoken CommunicationIndependent WorkPrioritizationStakeholder Decision-Making

Industry Keywords

European Medicines AgencyUS Food and Drug AdministrationPharmaceuticals and Medical Devices AgencyClinical DevelopmentMarket AccessProject Management

About the role

Key responsibilities & impact

Develop and execute regulatory activities supporting global drug development and lifecycle management
Plan and coordinate global regulatory submissions, including marketing authorisation applications, clinical trial applications and lifecycle-management submissions
Apply regulatory intelligence to develop submission strategies, plans, content structures and timelines
Prepare regulatory files and coordinate document creation, review and submission
Manage responses, commitments and follow-up activities arising from Health Authorities
Plan and support Health Authority interactions, including meeting requests, briefing packages, rehearsals and formal meeting documentation
Develop and maintain core labelling, including the Company Core Data Sheet and European labelling
Contribute to global regulatory strategies and identify opportunities to improve methods, processes and regulatory approaches
Provide regulatory guidance to stakeholders and mentor less-experienced colleagues when relevant
Collaborate with Clinical Reporting, Medical and Translational Science, Clinical Operations, Global Safety, Medical Affairs, Commercial, Legal, Quality and Regulatory Affairs teams
Engage with Health Authorities including the European Medicines Agency, US Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency and other regulatory agencies worldwide
Create alignment across professional disciplines, organisational areas and regions and support stakeholder decision-making

Requirements

What you’ll need

Master’s degree in life sciences combined with approximately 5-7 years of relevant experience, or a PhD combined with approximately 3-4 years of relevant experience
Bachelor’s degree in life sciences combined with approximately 8-11 years of relevant experience or equivalent knowledge gained through practical experience
Experience with regulatory submissions and requirements in one or more major markets, such as the EU, US, China or Japan
Knowledge of early- or late-stage drug development, lifecycle management, labelling or Health Authority interactions
Strong written and spoken English
Ability to interpret complex scientific and regulatory information and communicate it clearly to different audiences
Confidence working independently, setting priorities and managing several complex deliverables
Experience within clinical development, pharmacovigilance, medical devices, regulatory intelligence, market access or project management would be useful

Benefits

Comp & perks

Short-term and/or long-term incentives may be included
Other employee benefits based on position level, location, functional area and relevant market benchmarks
Diverse thinking, shared purpose and mutual respect