Regulatory Principal Specialist

Shape the regulatory strategy for cardiovascular programmes that could redefine treatment for millions – and do it at a stage where your decisions set the direction for everything that follows.

Your new role

As a Regulatory Principal Specialist in early development, you will own the regulatory strategy for cardiovascular programmes within Novo Nordisk A/S’s obesity and type 2 diabetes portfolio, guiding assets from early phases through to phase 3 readiness. This is a role where you design development programmes, lead health authority interactions, and drive strategic decisions that directly influence how quickly Novo Nordisk A/S can bring transformative therapies to patients.

Your key responsibilities will include:

• Developing and executing regulatory strategies for early-stage cardiovascular development programmes, ensuring a smooth and lean path forward.
• Planning and conducting health authority meetings, including preparation of meeting requests, packages, and leading rehearsals.
• Representing Regulatory Affairs in the Project Core Team, shaping the recommended development path and communicating direction to governance.
• Establishing and maintaining core labelling by linking the Target Product Profile to regulatory and market access requirements.
• Collaborating across programmes to identify synergies and drive efficiency with limited resources.
• Accountable for all regulatory submissions to health authorities worldwide, from CTAs/INDs through to pharmacovigilance documents.
• Acting as a regulatory expert across cross-functional teams, mentoring senior colleagues and contributing to best practices.

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. Novo Nordisk A/S combines curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, Novo Nordisk A/S shapes and delivers an innovative pipeline to meet future patient needs.

You will join a department of highly experienced regulatory leads who work with independence and accountability across early obesity and type 2 diabetes assets. The team collaborates closely across programmes where it makes sense – sharing approaches, aligning strategies, and finding smart ways to deliver with agility. With a super exciting pipeline of compounds and programmes coming through, this is a team where your impact today shapes what's possible tomorrow.

Your skills & qualifications

Novo Nordisk A/S is looking for a regulatory professional who thrives on strategic complexity and wants to leave a mark on programmes with global reach.

You'll bring with you:

• A Master of Science (life sciences) with 8–11 years of relevant regulatory affairs experience, or a PhD with 5–7 years of relevant experience.
• Proven experience as a regulatory lead, with deep knowledge of early-stage drug development and health authority interactions (FDA, EMA, PMDA).
• Experience working in affiliate or regional regulatory roles, providing you with a strong understanding of global regulatory landscapes and how strategies translate across markets.
• Excellent strategic thinking and the ability to translate regulatory intelligence into ambitious yet achievable development plans.
• Strong stakeholder management and communication skills, with the ability to present complex data convincingly and collaborate across functions and cultures.
• A background in cardiovascular development is preferred, though Novo Nordisk A/S welcomes candidates with strong regulatory experience across other therapy areas.
• RA CMC experience or RA device experience is a plus.
• Fluency in written and spoken English.

Working at Novo Nordisk

Novo Nordisk A/S is not chasing quick fixes – Novo Nordisk A/S is creating lasting change for long-term health. For over 100 years, Novo Nordisk A/S has been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives.

This dedication fuels Novo Nordisk A/S’s constant curiosity and inspires Novo Nordisk A/S to push the boundaries of what's possible in healthcare. Novo Nordisk A/S embraces diverse perspectives, seeks out bold ideas, and builds partnerships rooted in shared purpose.

Together, Novo Nordisk A/S is making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join Novo Nordisk A/S, you become part of something bigger – a legacy of impact that reaches far beyond today.

What Novo Nordisk A/S offers

At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. Novo Nordisk A/S offers 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 to 1,245,100 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.