CMC Submission Specialist

CMC Submission Specialist

Ready to drive the process of preparing successful drug registrations for Novo Nordisk? In Chemistry, Manufacturing & Control (CMC) Product & Process Development we are looking for a dedicated CMC Submission Specialist to help us shape, review and write high-quality CMC regulatory documents. If you bring your hands-on CMC expertise from API manufacturing to drug product release, strong regulatory submission experience, and have a keen interest in data-driven solutions, then we would like to hear from you

Come join us in CMC External Innovation & Submission team in a key contributor role delivering on high-impact work, apply today!

Your new role

As CMC Submission Specialist you will be a partner to the CMC Project Directors in the planning and preparation of the Quality section of the registration file, as well as participating in interactions including Q&A process with the Health Authorities. These tasks will typically take place in close collaboration with CMC submission team members, authors of individual CMC documents, and project managers from Regulatory Affairs, CMC, Product Supply and Device.

Your key responsibilities include:

• Review the whole Quality section of new drug applications for compliance and consistency, preparing selected documents and managing relevant training activities of authors
• Participate in planning and preparation of the overall document structure of the Quality section
• Support and contribute to establishing detailed storylines for individual documents
• Contribute to knowledge sharing within the CMC organisation based on feedback from Health Authorities

Your skills and qualifications

To succeed in this position, we believe you have a master’s degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar. Furthermore:  

• Solid knowledge (preferably at a specialist level) of the CMC value chain, as well as drug development and regulatory requirements
• Experience within the scientific field of API manufacturing processes and drug product development, including product characterisation, and analytical method development
• Several years of experience with contribution to regulatory submissions (FDA, EMA and ideally PMDA and NMPA-CDE), including preparing documents for the quality section
• Master the combination of technical insight, quality focus, and good communication, and you can see the potential of being a true expert in this specific area of expertise
• A high attention to detail to ensure consistency and alignment across all written documentation

We value candidates with a strong interest in data-driven solutions and applied AI. A flair for IT and enthusiasm for advanced analytics and AI tools will help build the team's future capabilities.

You are a team player also having the ability to work independently. You possess excellent collaboration skills combined with a structured way of working and have a good sense of humour.

Your new area

The CMC External Innovation and Submission department is a part of CMC Product & Process Development and plays a significant role in bringing new medicinal products to the market. The department has two primary responsibilities: (1) leading due diligence and integration of external assets on behalf of CMC & Product Supply, and (2) supporting regulatory submissions to health authorities by ensuring high-quality regulatory dossiers. We are a team of approximately 10 colleagues based in Bagsværd, Denmark.

We offer a modern and flexible working environment, giving everyone the opportunity to be themselves and do their best, whilst working with truly talented colleagues. While we are dedicated to our tasks, we maintain focus on preserving a healthy work-life balance.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

More information

For questions, please contact Principal CMC Submission Specialist Ann-Kristin Bentsen at +45-30797532 or Senior Director Dennis Hansen at +45 30751567.

Deadline

15 February 2025.

Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. 

You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV.

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.