Regulatory CMC Development Lead — Global Strategy

Novo Nordisk A/S; Søborg; On-site; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk A/S is seeking a Regulatory Principal Specialist in RA CMC Development, based in Søborg, Copenhagen. You will provide strategic leadership across global development activities, drive regulatory submissions, and coordinate with health authorities to support global patient access.

The role emphasizes independent decision-making, cross-functional alignment, and influencing regulatory strategy across indications and modalities in a truly global context.

Qualifications

• Master's degree with significant Regulatory Affairs experience.

Responsibilities

• Lead global regulatory CMC strategies and execution for early development.

Skills

Regulatory strategy

CMC development

Global health authority interactions

Stakeholder management

Scientific/technical writing

English fluency

Education

Master's degree in Regulatory Affairs

Job description

Novo Nordisk A/S is seeking a Regulatory Principal Specialist in RA CMC Development, based in Søborg, Copenhagen. You will provide strategic leadership across global development activities, drive regulatory submissions, and coordinate with health authorities to support global patient access.

The role emphasizes independent decision-making, cross-functional alignment, and influencing regulatory strategy across indications and modalities in a truly global context.