Global Regulatory CMC Lead, Early Development

Novo Nordisk A/S; Denmark; Remote; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Principal Specialist to lead global CMC regulatory strategies across early development and diverse modalities. You will influence health authority interactions and shape submission plans with cross-functional partners.

The role requires a Master’s degree in regulatory affairs, deep regulatory knowledge, and a proven track record in managing risk and driving decisions in international teams.

Qualifications

• A Master's degree with significant Regulatory Affairs experience.
• Deep knowledge of global regulatory requirements, including drug development and health authority interactions.
• Strong understanding of CMC development, manufacturing, and the pharmaceutical value chain.
• Demonstrated experience in leading complex regulatory CMC projects with international stakeholders.
• Proven track record of managing regulatory risks and translating challenges into clear, actionable advice.
• Excellent communication, negotiation, and stakeholder management skills, fluent in English.

Responsibilities

• Leading global regulatory CMC strategies and execution for early development across indications and modalities.
• Managing interactions with global health authorities, including briefing documents and meeting strategies.
• Acting as Regulatory Affairs CMC Lead, aligning across Regulatory Affairs, CMC Development, QA, Clinical Supply and affiliates.
• Representing Regulatory Affairs in cross-functional matrix teams to drive strategic alignment.
• Contributing to innovation, regulatory intelligence, and external industry engagement through working groups.

Skills

Regulatory strategy

Stakeholder management

English communication

Cross-functional collaboration

Education

Master's degree in Regulatory Affairs

Job description

Novo Nordisk A/S in Søborg, Denmark, seeks a Regulatory Principal Specialist to lead global CMC regulatory strategies across early development and diverse modalities. You will influence health authority interactions and shape submission plans with cross-functional partners.

The role requires a Master’s degree in regulatory affairs, deep regulatory knowledge, and a proven track record in managing risk and driving decisions in international teams.