Regulatory Affairs Specialist

Regulatory Professional II

   

Company: Novo Nordisk Global Business Services (GBS)

Are you ready to shape how life-changing medicines reach patients across the globe? Join us as a Regulatory Professional II and play a pivotal role in driving timely submissions to Health Authorities worldwide, while strengthening Novo Nordisk's regulatory excellence across diverse markets.

 

Your new role
As a Regulatory Professional II, you will be responsible for making timely submissions to Health Authorities worldwide. You will establish and maintain the CMC part of the core regulatory file, while playing a key role in Life Cycle Management and stakeholder engagement across global and affiliate environments.

Your day-to-day responsibilities will include:

• Supporting submission planning by applying regulatory intelligence, developing regulatory strategy, and creating and maintaining the Regulatory Submission Plan, including creation and review of documents
• Supporting the submission of regulatory files, handling Change Requests and Deviations, responding to RSI/HA queries worldwide, Annual Reporting and maintenance of marketing authorisations globally
• Supporting NDA roll-outs, Renewals and Post Approval Changes across regulated and emerging markets
• Working hands-on with Veeva Vault (Submissions & Registrations) to ensure efficient and compliant regulatory operations
• Managing stakeholders effectively and ensuring appropriate use of communication channels to strengthen relationships across the business
• Collaborating across countries, cultures and time-zones to ensure minimum time-to-market for our products

 

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.

Regulatory Affairs plays an important role in ensuring all Novo Nordisk medicines and devices are developed with compliance and patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs is involved throughout the phases of product development, NDA and maintenance of LCM activities. Our people in Regulatory Affairs come from diverse academic and professional backgrounds, bringing valuable insights and expertise to the team – making this a truly multi-disciplinary place to work with high professional standards and excellent opportunities for fast-paced professional development.

 

Your skills & qualifications
We're looking for a driven and proactive professional who thrives in a dynamic, global environment and brings both strategic thinking and hands-on regulatory expertise. To succeed in this role, you will bring:

• 6+ years of experience within Regulatory Affairs, with a Graduate or Postgraduate degree in Life-Science, Chemistry, Pharmacy, Medicine or Biotechnology Engineering
• A good understanding of end-to-end Regulatory Processes and Life Cycle Management, with strong RA-CMC knowledge and commercial acumen, and a clear understanding of the pharma/biotech value chain
• Diverse regulatory experience across regulated and emerging markets and various dosage forms; experience working in both global and affiliate environments and with China and Japan will be preferred
• Bold personality with proven negotiation skills, excellent project management skills, and the ability to confidently put forward facts and convince stakeholders
• Highly proactive with the ability to take initiative, manage multiple priorities, and engage with colleagues across countries and cultures with high cultural sensitivity
• Excellent written and spoken English communication skills, paired with a self-managed, results-oriented mindset

 

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
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
22 June 2026. (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

Senior Level