Global Regulatory CMC Lead for Early Development

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

Job summary

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Principal Specialist in RA CMC Development to provide strategic leadership across global regulatory submissions and health authority interactions, enabling timely access to innovative therapies.

You will drive global CMC strategies, collaborate with Clinical Supply, QA, and affiliates, and guide governance discussions in an international environment to advance patient outcomes.

Qualifications

• Master's degree with significant Regulatory Affairs experience.
• Deep knowledge of global regulatory requirements across major markets.
• Strong understanding of CMC development and the pharmaceutical value chain.
• Experience leading complex regulatory CMC projects and cross-functional collaboration.
• Proven ability to manage regulatory risks and communicate with governance bodies.
• Excellent written and spoken English communication.

Responsibilities

• Lead global regulatory CMC strategies and execution for early development.
• Manage interactions with health authorities, including briefing documents and meeting strategies.
• Act as Regulatory Affairs CMC lead, aligning Regulatory Affairs, CMC Development, QA, Clinical Supply, and affiliates.
• Represent Regulatory Affairs in cross-functional matrix teams and drive alignment.
• Contribute to regulatory intelligence, process improvements, and external engagement.
• Operate with independence and accountability to solve complex regulatory challenges.

Skills

Regulatory Affairs

CMC development

Global regulatory strategy

Leadership

Stakeholder management

English fluency

Education

Master's degree

Job description

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Principal Specialist in RA CMC Development to provide strategic leadership across global regulatory submissions and health authority interactions, enabling timely access to innovative therapies.

You will drive global CMC strategies, collaborate with Clinical Supply, QA, and affiliates, and guide governance discussions in an international environment to advance patient outcomes.