Principal Regulatory Strategy Lead, CMC & Global Submissions

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk in Denmark is seeking a Regulatory Principal Specialist in RA CMC Development to lead regulatory strategies across proteins, peptides, and complex modalities from early development to global submissions. You will act as a regulatory expert, shaping submissions, guiding agency interactions, and aligning strategies with business priorities.

You will lead cross-functional teams across Regulatory Affairs, CMC Development, Quality Assurance, Clinical Supply, and affiliates, driving

Qualifications

• Master's degree with significant Regulatory Affairs experience.
• Deep knowledge of global regulatory requirements and health authority interactions across major markets.
• Strong understanding of CMC development, manufacturing, and pharma value chain.
• Experience leading regulatory CMC projects, influencing cross-functional stakeholders, and driving strategic decisions in an international environment.
• Proven ability to translate regulatory risks into actionable guidance for governance bodies.
• Excellent communication, negotiation, and stakeholder management skills, with fluency in English.

Responsibilities

• Lead global regulatory CMC strategies and execution for early development across indications and modalities.
• Manage interactions with global health authorities, including briefing documents, meeting strategies, and responses to agency questions.
• Act as a Regulatory Affairs CMC Lead, ensuring alignment across Regulatory Affairs, CMC Development, QA, Clinical Supply, affiliates, and other stakeholders.
• Represent Regulatory Affairs within cross-functional matrix teams, driving strategic alignment and information sharing across functions.
• Contribute to innovation, process optimisation, regulatory intelligence, and external industry engagement through working groups and stakeholder forums.
• The role requires independence and decision-making authority, with accountability for solving complex regulatory challenges and supporting business objectives across global markets.

Skills

Regulatory affairs experience

Global regulatory knowledge

CMC development

Cross-functional leadership

Stakeholder management

English fluency

Education

Master's degree in Regulatory Affairs or related field

Job description

Novo Nordisk in Denmark is seeking a Regulatory Principal Specialist in RA CMC Development to lead regulatory strategies across proteins, peptides, and complex modalities from early development to global submissions. You will act as a regulatory expert, shaping submissions, guiding agency interactions, and aligning strategies with business priorities.

You will lead cross-functional teams across Regulatory Affairs, CMC Development, Quality Assurance, Clinical Supply, and affiliates, driving