Regulatory Affairs Specialist

Novo Nordisk

Regulatory Affairs Specialist leading regulatory submission activities for late-stage development programs at Novo Nordisk. Collaborating globally on marketing authorisation strategies for obesity therapies.

Posted 7/23/2026full-timeSøborg • 🇩🇰 DenmarkSeniorLead💰 DKK 742,600 - DKK 1,091,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Regulatory Affairs with a focus on global marketing authorisation submissions and regulatory strategy across development projects. Proven ability to lead cross-functional teams and drive innovative submission strategies in the pharmaceutical industry.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Marketing Authorisation ApplicationsRegulatory Strategy DevelopmentNegotiation SkillsLife Cycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission StrategyComplex Development Programme ManagementSubmission ExecutionPharmaceutical Value Chain UnderstandingLife Science Knowledge

Soft Skills

Excellent Communication SkillsStrong Decision-MakingTeam LeadershipCollaboration

Certifications & Qualifications

Master's DegreePh.D. Degree

Industry Keywords

Obesity TherapyCardiometabolic HealthRegulatory Submission TeamCross-Functional StakeholdersDevelopment Projects

About the role

Key responsibilities & impact

Contributing to the late-stage development strategy for one of Novo Nordisk's key assets within the obesity and cardiometabolic health therapy area
Developing and planning the global marketing authorisation submission strategy for a highly complex development programme pursuing multiple indications
Driving innovative and fit-for-purpose submission strategies, including exploring new ways of structuring and executing submissions to support complexity, speed, and quality
Leading and guiding the regulatory submission team and cross-functional stakeholders to ensure aligned execution, strong decision-making, and timely delivery of submission activities
Working across development projects in combination with life cycle management activities, ensuring a coherent and forward-looking regulatory strategy

Requirements

What you’ll need

A Master's or Ph.D. degree in Life Science, Pharmaceutical or Health Science
Minimum 7–8 years of experience in Regulatory Affairs with solid, hands-on experience in global marketing authorisation applications
Proven experience working with regulatory strategy across development projects and life cycle management
Strong negotiation skills and a sound understanding of the pharmaceutical value chain
Excellent communication skills with the ability to cooperate at any organisational level
Fluency in written and spoken English.

Benefits

Comp & perks

Continuous learning
Career development
Benefits tailored to your life and career stage