Submission Specialist

Do you want to have an impact on how we write regulatory submission documents for approval of new finished products across Novo Nordisk’s injectables portfolio? Do you thrive in an environment where you can ensure a smooth process and interaction with health authorities throughout a submission and Q&A process?

Then you could be our new submission specialist role and join a team that will set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new injectable drug products.

 
The position
We are now hiring a submission specialist who will be involved in developing the vision and setting the direction for how we work with regulatory documents going forward.

Your main tasks will be to:

• Define and keep the overview of the regulatory storyline.
• Create documentation for our portfolio to ensure that the required product's quality is fulfilled and thereby, securing patients’ safety.
• Review and implement new documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities.
• Use your regulatory expertise to provide feedback, secure answers to questions from various health authorities and keep in touch with them.
• Structure and coordinate a complex documentation and submissions portfolio.
• Identify and implement new tools and ways of working to simplify and streamline submissions for new and existing products.
   

You will do this in cooperation with your colleagues across three areas in Aseptic Manufacturing Science and Technology (AMSAT) and with close interactions with the development departments (CMC), QC, QA, production, and regulatory affairs.
 

We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills and flexibility.
 

Qualifications 
The qualifications we are looking for are:

• An academic degree in Science within Pharmacy, Chemistry, Engineering or a similar field.
• Experience either from the pharmaceutical industry, the regulatory area or from the health authorities with either writing or reviewing regulatory documents.
• Great communication skills in English, both spoken and written.
• Excellent ability to plan and coordinate the writing work in line with an ambitious submission strategy.
• Ability to set the direction for building a regulatory submissions competence- and collaboration hub in Novo Nordisk Product Supply
• You are good at creating an overview and prioritizing your tasks, even when deadline approaches.
   

As a person, you are open, honest, and curious and do well in busy environments. You enjoy working through complexity and have a keen interest in strategy and a holistic mindset that enables you to work effectively across organizational boundaries. Challenges do not scare you, and a quality mindset is at your core. Time management is well appreciated, as well as being an engaged team player.

We encourage you to apply even if you do not meet all the listed qualifications but possess relevant skills and experience.

About the area/department
In Aseptic Manufacturing (AM) we produce our many high-quality injectable products for diabetes, bleeding disorders, growth hormone, and obesity, and the AMSAT organisation is a global function, supporting all our manufacturing sites worldwide with process, product, and analytical expertise. New Product Introduction (NPI) consists of 90 employees, and we are currently located in Søborg. The main responsibility of the area is the transition of development drug products into large scale production. This includes production design, material and process sciences, product stability incl. specification setting and trending, coordination of manufacturing for late-phase clinical trials, and filing for market approval with health authorities. 

The Submissions specialist will have their base in the Submissions and Reference Materials department in NPI which was formed at the start of 2025. The team provides support with regulatory writing across three areas within AMSAT, Product Life Cycle Management, Manufacturing Science and Transfers and NPI. The team consists of a group of regulatory professionals and submission specialists each being a key part of securing approval of new drug products and launch in the market.

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 further information you are welcome to contact the hiring manager: Maria Berggård Silow at +45 34 48 50 56

Deadline 
22 June 2025

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo 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.