Global Regulatory CMC Lead – Early Development

Cari; København; Hybrid; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk in Copenhagen seeks a Regulatory Principal Specialist in RA CMC Development to shape regulatory strategy for diverse modalities and drive submissions across global markets.

You will lead global CMC strategies, interact with health authorities, align with QA, Clinical Supply and affiliates, and mentor teams. A Master’s degree and strong cross‑functional leadership in regulatory affairs with English fluency are essential.

Qualifications

• Master's degree with substantial Regulatory Affairs experience.
• Deep knowledge of global regulatory requirements and health authority interactions.
• Strong understanding of CMC development and pharma value chain.
• Experience leading complex regulatory CMC projects across functions.
• Proven ability to manage regulatory risks and advise governance bodies.
• Excellent communication, negotiation, and stakeholder management 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 and meeting strategies.
• Act as Regulatory Affairs CMC Lead, aligning across Regulatory Affairs, CMC Development, QA, Clinical Supply, and affiliates.
• Represent Regulatory Affairs in cross-functional matrix teams and drive strategic alignment.
• Contribute to regulatory intelligence and external engagement through study groups.
• Operate with independence and decision-making authority to support business objectives.

Skills

Regulatory strategy

CMC development

Health authority interactions

Cross-functional leadership

English fluency

Risk management

Education

Master's degree in Regulatory Affairs

Job description

Novo Nordisk in Copenhagen seeks a Regulatory Principal Specialist in RA CMC Development to shape regulatory strategy for diverse modalities and drive submissions across global markets.

You will lead global CMC strategies, interact with health authorities, align with QA, Clinical Supply and affiliates, and mentor teams. A Master’s degree and strong cross‑functional leadership in regulatory affairs with English fluency are essential.