Regulatory Principal Specialist, RA CMC Development, Copenhagen

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

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Regulatory Principal Specialist, RA CMC Development, Copenhagen

Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

Shape the regulatory strategy of tomorrow's medicines. Join RA CMC Development and lead at the forefront of an exciting pipeline spanning proteins and peptides, small molecules, antibodies, oligonucleotides and gene therapies, accelerating innovation from science to patients.

Are you a highly experienced Regulatory Affairs expert with deep expertise in CMC and global regulatory strategy? Do you thrive in a complex international environment where scientific insight, strategic leadership, and collaboration are essential to bringing innovative therapies to patients worldwide? If so, we may have the perfect opportunity for you.

Your new role

As Regulatory Principal Specialist in RA CMC Development, you will serve as a recognized regulatory expert, providing strategic leadership across global and early development activities. You will be responsible for driving regulatory submissions, influencing health authority interactions, and ensuring regulatory strategies support business and patient needs worldwide.

Your responsibilities will include:

• Leading global regulatory CMC strategies and execution for early development across indications and modalities.
• Managing interactions with global health authorities, including preparation of briefing documents, regulatory meeting strategies, and responses to agency questions.
• Acting as a Regulatory Affairs CMC Lead, ensuring alignment across Regulatory Affairs, CMC Development, Quality assurance, Clinical Supply, affiliates, and other key 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, study groups, and stakeholder forums.
• The role requires a high degree of independence and decision-making authority, with accountability for solving complex regulatory challenges and supporting key business objectives across global markets.

Your new department

You will join a highly specialised global Regulatory Affairs CMC organisation responsible for developing and executing regulatory strategies that support innovative treatments in early development. The team collaborates closely with experts across Product Supply, CMC Development, Global Research, Clinical Operations, Medical Affairs, Safety, Device Development, Marketing, and affiliates worldwide.

Working in a truly global setting, you will engage with regulatory authorities such as the FDA, EMA, and other agencies. This is a unique opportunity to influence regulatory thinking, contribute to strategic business decisions, and help ensure timely access to life-changing therapies for patients worldwide.

Your skills and qualifications

To succeed in this role, we imagine that you have:

• A Master's degree with significant Regulatory Affairs experience.
• Deep knowledge of global regulatory requirements, including drug development, and health authority interactions across major markets.
• Strong understanding of CMC development, manufacturing, , and the pharmaceutical value chain.
• Demonstrated experience in leading complex regulatory CMC projects, influencing cross-functional stakeholders, and driving strategic decision-making in an international environment.
• Proven track record of managing regulatory risks and translating challenges into clear, actionable advice for governance bodies and experts outside Regulatory Affairs, ensuring risk transparency and informed decision-making.
• Excellent communication, negotiation, and stakeholder management skills, combined with fluency in written and spoken English.

As a person, you are proactive, accountable, and able to navigate complexity with confidence. You build strong relationships across functions and cultures, inspire collaboration, and continuously seek opportunities to improve processes and outcomes. You are comfortable making difficult decisions, balancing scientific insight with business priorities, and acting as a trusted advisor to internal and external stakeholders.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary:

For this role, the Annual Base Salary ranges from 847,000.00 to 1,245,100.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits:

The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Deadline

25th September 2026

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.