Sr Regulatory Professional / Associate Specialist

Sr Regulatory Professional / Associate Specialist

   

Company: Novo Nordisk Global Business Services (GBS)

 

Shape global regulatory strategies that bring innovative therapies from pipeline to patients – navigating complex health authority landscapes across the world while driving the future of how we work with regulatory science.

 

Your new role

In this role, you will take ownership of regulatory strategies and submissions across global markets, acting as a key driver in ensuring our therapies reach patients efficiently and compliantly. You will operate at the intersection of science, strategy, and stakeholder management – balancing deep regulatory expertise with cross-functional collaboration.

Your key responsibilities span across several areas:

Regulatory submissions to health authorities worldwide

• Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies
• Prepare, submit, and maintain regulatory files including MAA/NDA/BLA, CTA/IND, Site Master Files, renewals, post-approval changes, and commitments
• Respond to questions from health authorities and maintain marketing authorisations globally
• Manage interactions with affiliates to ensure aligned and timely execution

Regulatory interactions with health authorities

• Plan and conduct regulatory interactions with health authorities, including preparation of meeting requests, meeting packages, rehearsals, and formal meeting minutes
• Provide strategic input to affiliates for preparation of health authority interactions

RA matrix team membership

• Represent the Regulatory Affairs function in the RA matrix team, ensuring alignment of planning and strategy across areas
• Drive effective information flow to the matrix team to support decision-making

Monitor and renewals handling

• Drive monitoring of upcoming submissions in Vault RIM, assess required national documentation, and conduct high-level planning
• Own the overall planning and initiation of global renewals

Role as Global RA CMC Lead

• Be accountable for the overall RA CMC/Device regulatory strategy, including DDC products
• Align with Product Supply, affiliates, and GRL for timely progress of activities
• Inform Line of Business about business-critical decisions, resource constraints, and unforeseen events

Beyond these core areas, you will also act as substitute for more senior regulatory roles, represent RA in stakeholder working groups and core groups, drive innovation and optimisation projects, and serve as Process Change Champion – including impact assessment of change requests and deviations.

 

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

Within R&D, you will join our Regulatory Affairs organisation, where we guide products through the global regulatory landscape – from early development through life cycle management. Our team combines deep scientific expertise with strategic thinking to ensure that our therapies reach the patients who need them, on time and in compliance with regulatory requirements across all major markets. You will work alongside experienced regulatory professionals who share a commitment to excellence and a passion for making a difference.

 

Your skills & qualifications

We are looking for someone who thrives in complexity and brings both strategic insight and hands-on regulatory expertise. You will bring with you:

• A Master's degree with typically 5–7 years of relevant experience, or a PhD with typically 3–4 years of relevant experience across several of the qualifiers below. If you hold a Bachelor's degree, typically 7–9 years of relevant experience is expected
• Solid knowledge of regulatory science and requirements across key markets (EU, US, China, Japan), with experience in areas such as late-stage drug development, life cycle management, health authority interactions, or CMC development
• Experience with regulatory submissions, label development, regulatory intelligence, or device development – ideally across multiple of these areas
• Demonstrated experience assessing and managing regulatory requirements and impacts related to manufacturing facilities, manufacturing processes, and associated changes
• A strategic mindset with the ability to navigate ambiguity, manage variable workloads, and make bold decisions based on risk evaluation
• Strong interpersonal skills with the ability to collaborate openly across functions, display an inclusive mindset, and deliver high-impact results in a complex stakeholder landscape
• Fluency in written and spoken English

 

Working at Novo Nordisk

At Novo Nordisk, your work connects directly to patients battling serious chronic diseases around the world. For over a century, we have combined scientific curiosity with operational excellence to develop and deliver therapies that transform lives. Here, you will find driven colleagues who push each other to go further, a culture that values both accountability and collaboration, and the opportunity to grow within one of the most exciting pipelines in the industry. We invest in our people as whole persons – supporting your development, your wellbeing, and your sense of belonging at every stage of your career.

 

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

 

Deadline

7 August 2025. Applications are reviewed on an ongoing basis.

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.

Experience Level

Mid Level