Global Regulatory CMC Lead, Development Strategy

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

Benefits offered by this job

Competitive salary

Continuous learning

Career development

Job summary

Novo Nordisk is seeking a Regulatory Principal Specialist in RA CMC Development to lead global regulatory strategies for early development across modalities. You will influence health authority interactions and drive submissions that support patient access worldwide.

The role requires a Master’s in Regulatory Affairs, deep CMC expertise, and a proven ability to align cross-functional teams across Product Supply, Quality, Clinical, and Affiliates in a fast-paced, international environment.

Qualifications

• Master's degree in Regulatory Affairs or equivalent.
• Deep knowledge of global regulatory requirements across drug development.
• Strong CMC development and health authority interaction experience.
• Proven ability to lead complex regulatory projects and guide governance bodies.

Responsibilities

• Leading global regulatory CMC strategies and execution for early development across indications and modalities.
• Managing interactions with global health authorities, including briefing documents, regulatory meeting strategies, and responses to agency questions.
• Acting as a Regulatory Affairs CMC Lead, ensuring alignment across Regulatory Affairs, CMC Development, QA, Clinical Supply, affiliates, and other stakeholders.
• Representing Regulatory Affairs within cross-functional matrix teams, driving strategic alignment and information sharing across functions.
• Contributing to innovation, process optimisation, regulatory intelligence, and external industry engagement through working groups and stakeholder forums.

Skills

Regulatory affairs

CMC knowledge

Cross-functional leadership

Stakeholder management

English communication

Education

Master's degree in Regulatory Affairs

Job description

Novo Nordisk is seeking a Regulatory Principal Specialist in RA CMC Development to lead global regulatory strategies for early development across modalities. You will influence health authority interactions and drive submissions that support patient access worldwide.

The role requires a Master’s in Regulatory Affairs, deep CMC expertise, and a proven ability to align cross-functional teams across Product Supply, Quality, Clinical, and Affiliates in a fast-paced, international environment.