Are you interested in being a key contributor within Chemistry, Manufacturing & Control (CMC) in the process of preparing successful drug registrations for Novo Nordisk? We are looking for a dedicated CMC Submission Specialist to help shape, review and write high-quality CMC regulatory documents. If you bring a strong scientific foundation in CMC development (from manufacturing of active pharmaceutical ingredients to final drug product release) and are ready to make an impact in a dynamic, high-stakeholder environment, then this job may be just the right next step in your career. Come join us, apply today!
The Position
As CMC Submission Specialist you will work as 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
Qualifications
To succeed in this position we believe you have:
A Master Degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar 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
Lastly, 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 humor.
About the area
Development Product Portfolio (DPP) is a CVP area established to improve Novo Nordisk’s ability to prioritise and develop our pipeline with a keen focus on product potential, manufacturability, scalability, as well as future capacity needs in close collaboration with the Global Supply Chain.
You will join the area DPP Excellence & Transformation within DPP, where the position is based in the Submission & Trade Secrets team. DPP Excellence & Transformation have the key purpose of ensuring project excellence and portfolio management across DPP. The Submission & Trade Secrets team are responsible for planning and managing the CMC part of the entire Novo Nordisk portfolio of development projects. This includes preparation of CMC documentation for submission to Health Authorities, where we support the registration phase of new medicinal products, including planning and execution of the different stages and elements of the entire registration process.
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
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For questions, please contact Principal CMC Submission Specialist Ann-Kristin Bentsen at +45-30797532 or Project Vice President Helle Susanne Rolsted at +45 30758886.
Deadline
30 May 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 recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.