Regulatory Writer

Are you passionate about technical writing and regulatory submission process? Do you thrive in a dynamic international environment with many stakeholders, including contract manufacturers? If you would like to join a team where we, among other exciting tasks, hold the responsibility of writing regulatory submission documents related to aseptic manufacturing of drug product - then apply now and join us in Global Contract Manufacturing Drug Product Manufacturing Science and Technology (GCM DP MSAT) Support! The position As a Regulatory Writer, your primary task will be to prepare the regulatory documents related to Module 3, CTD sections for submission in different regions. Your role also involves defining the regulatory storyline in collaboration with Regulatory Affairs and create documentation for our portfolio to ensure that the required product’s quality is fulfilled and thereby secure the safety of our patients. Some of your main tasks include:

Writing and reviewing regulatory submission documents related to aseptic manufacturing of our drug products

Collaborating closely with your colleagues in regulatory affairs, QC, contract manufacturers, production, and development departments

Assisting on answering questions from global health authorities related to our regulatory submission

Updating the regulatory documents based on the latest change requests during the life cycle management of the products

Due to the nature of this role, relocation to Denmark is necessary. Qualifications To be successful in this role, we believe you:

Hold a master’s degree in science within Pharmacy, Chemistry, Engineering, or a similar field

Have experience either from the pharmaceutical industry, the regulatory area, or from the health authorities with either writing or reviewing regulatory documents

Showcase fondness for writing and adeptness at creating overviews and prioritizing your tasks even when deadline approaches

Demonstrate project management skills, consistently achieves multiple tasks and goals on-time, coupled with a passion for communication

Display fluency in both spoken and written English

In addition to the technical skills, we value personal contributions and teamwork. Therefore, the ideal candidate should be able to work independently with a positive can-do attitude, think through problems clearly and logically, and adapt to changing conditions. At Novo Nordisk, we value both hard and soft skills, and we believe that the right candidate should possess a combination of both to maintain a good work environment. Furthermore, the right candidate shares our view that the whole is greater than the sum of the individual parts as we believe that teamwork divides the task but doubles the success. About The Department GCM DP MSAT is physically located in Søborg, Denmark but we will move to our new site in Tastrup by the end of 2024. We are 23 engaged and open-minded colleagues organised in 2 teams. One of this is GCM DP MSAT Support, where we are responsible for the daily support of project activities of aseptic productions outsourced to contract manufacturers. You will join a well-functioning team where we work and solve problems in collaboration. The every-day work in our team can shift in many directions and therefore it is good if you can approach new situations with an open mind. Working at [xxxxx] We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at [xxxxx], life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information about the position, please contact Karina Ayala on +[xxxxx]or [xxxxx] Deadline 3 July 2024. 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 to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.