Regulatory Affairs CMC Specialist

Novo Nordisk

Regulatory Affairs CMC Specialist shaping global regulatory pathways for Novo Nordisk. Driving CMC activities and ensuring compliance in late-stage product development for healthcare.

Posted 5/12/2026full-timeSøborg • 🇩🇰 DenmarkSeniorLead💰 DKK 742,600 - DKK 1,091,600 per yearWebsite

About the role

Key responsibilities & impact

Support selected products in the Novo Nordisk portfolio, focusing on late-stage development and life-cycle management submissions across global markets
Lead and drive strategic regulatory CMC activities to ensure timely approvals and compliance
Translate pharmaceutical operations knowledge into robust global regulatory CMC strategies
Apply CMC regulatory intelligence to strengthen submissions and regulatory pathways
Plan, coordinate and review regulatory documentation, including submission modules and responses to health authority questions
Contribute to continuous improvement of regulatory CMC practices, processes and documentation

Requirements

What you’ll need

A Master’s degree and/or PhD in a relevant scientific field
Extensive experience from the pharmaceutical industry and/or a health authority
At least 8 years of relevant experience within Regulatory Affairs CMC or a closely related area; experience with drug-device combination products is an advantage
Strong project management skills and the ability to navigate complex stakeholder landscapes
Excellent English communication skills, both written and spoken, and the ability to work effectively in multidisciplinary, international teams.

Benefits

Comp & perks

short-term and/or long-term incentives
other employee benefits based on position level, location, functional area and relevant market benchmarks

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory CMCpharmaceutical operationsregulatory documentationsubmission modulesregulatory intelligencedrug-device combination productslife-cycle managementglobal regulatory strategiescompliancecontinuous improvement

Soft Skills

project managementcommunicationstakeholder managementteam collaborationmultidisciplinary teamworkstrategic thinkingproblem-solvingleadershiporganizational skillsadaptability

Certifications

Master’s degreePhD