Quality Control Regulatory Writer

Are you passionate about writing and the regulatory submission process, and do you have experience from working within the analytical or regulatory field? Do you want to make a difference and change the life of patients with rare diseases? Then apply today and join our team! The position
As Regulatory Writer you will be responsible for defining the regulatory storyline and create documentation for our portfolio of products to ensure that the required product quality is fulfilled and thereby secure the safety of our patients. You will write and review regulatory submission documents related to the analytical field such as analytical procedures and validation reports. Our regulatory submissions cover health authorities across the globe, and you will also take part in the process of answering questions from health authorities related to our submission. You will do all of this and more in cooperation with colleagues in your new department, BRD Analytical Manufacturing Development. We are responsible for the analytical side of preparations for phase 3 clinical trials, submission and much more. Also, you will collaborate with colleagues from other parts of manufacturing development, quality control, quality assurance, manufacturing facilities and regulatory affairs. You will take part in shaping the way we write our regulatory documents based on continuous learnings and feedback. Finally, you will join a harmonious team and department with competent, caring, and positive colleagues. We have a strong foundation of employees with high seniority mixed with more recent newcomers. Novo Nordisk is a great place to work, and our internal engagement survey scores are well above average. Qualifications
To succeed in this role, you have:
• An academic degree within Pharmacy, Chemistry, Engineering, or similar.
• Experience either from the pharmaceutical industry, the regulatory area or from the health authorities with either writing or reviewing regulatory documents will be an advantage.
• Experience of working within the analytical field will be an advantage.
• Excellent skills at creating an overview and prioritizing your tasks.
• A passion for writing with full professional proficiency in English.
On a personal note, you have a structured and detail-oriented approach to everything you do. You take pride in delivering high quality documents and to do so you build and create a network to improve your knowledge and skills. About the department
BRD Manufacturing Development & Quality Control has its base in Denmark. What other companies call Manufacturing Science & Analytical Technology (MSAT) we call Manufacturing Development. We are app. 460 colleagues who are the end-to-end station for product and process development for all BRD production facilities, driving innovation both when it comes to industry 4.0 technology and expansion of the product portfolio. Our area also includes the Quality Control unit for all BRD’s products. Together we drive change by always looking for improvements within our processes and in the way we work to make our products reach as many patients as possible. Working at Novo Nordisk, Biotech & Rare Disease
Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and in quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2500 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact
If you have any questions about the position, please contact Associate Manager Julie Kruse Jensen at +45 30 77 50 11. Deadline
19 March 2023. Please apply as soon as possible as we will be conducting interviews on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences in your resume or CV about why you are applying for the job. 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 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.