Regulatory Affairs Specialist – RA Manufacturing Facilities, Projects

Novo Nordisk

Regulatory Affairs Specialist leading projects in manufacturing facilities across Diabetes, Obesity, and Rare Disease portfolios. Responsible for submissions, approvals, and regulatory strategies at Novo Nordisk.

Posted 5/28/2026full-timeSøborg • 🇩🇰 DenmarkSeniorLead💰 DKK 742,600 - DKK 1,091,600 per yearWebsite

About the role

Key responsibilities & impact

Be accountable for and lead end-to-end regulatory submission activities for cross-product, cross-site, and manufacturing facility/equipment change projects.
Contribute to new product submissions by leading regulatory strategies and activities related to manufacturing facilities and equipment.
Coordinate activities related to the creation and maintenance of dossier documentation for manufacturing facilities, manufacturing equipment, and associated processes (such as cleaning validation, sterilisation, environmental monitoring, media-fill etc).
Demonstrate strong leadership by setting the strategic regulatory direction for projects.
Acting as an RA Site Partner by fostering close collaboration with manufacturing sites to proactively align on planned site-level changes.

Requirements

What you’ll need

A university degree in Pharmaceutical Engineering, Life Sciences, or a related field.
At least 8 years of relevant experience within regulatory affairs, manufacturing, and quality in the pharmaceutical industry.
Proven experience with regulatory submissions and approvals, including interactions with health authorities.
Demonstrated track record of driving regulatory strategies for the approval of new or revamped manufacturing facilities, supported by strong GMP knowledge and expertise.
Hands-on experience working in environments characterised by tight timelines, high complexity, and diverse, non-standard tasks.
Strong project management skills, with the ability to navigate complex stakeholder landscapes effectively.
Fluency in both spoken and written English is essential to ensure clear communication and effective collaboration across functions and geographies.

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 submissionsregulatory strategiesGMP knowledgedossier documentationcleaning validationsterilisationenvironmental monitoringmedia-fillproject managementmanufacturing processes

Soft Skills

leadershipcollaborationcommunicationstrategic directionstakeholder managementproblem-solvingadaptabilitytime managementteamworkcritical thinking