Academic to write regulatory documents

Are you ready to make a difference for people living with haemophilia and other rare diseases? Are you passionate about writing the regulatory submission process and the subsequent Q&A process? Do you have experience from working with API manufacturing processes and/or the regulatory field? We are looking for a new colleague to our regulatory writer team, so here is the possibility to join a team that set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new treatments for haemophilia and other chronic rare diseases. The position It will be your responsibility to define the regulatory storyline in collaboration with Regulatory Affairs. You will create documentation for our portfolio of products in Biotech & Rare Disease (BRD) 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 BRD’s manufacturing processes of API’s. 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 API Manufacturing Development. 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, and you will be a part of a Regulatory Writer Network across API, Drug Product, and Analytical Procedures in BRD. Together you strive for developing and improving the regulatory writing in BRD. Qualifications To succeed in this role, you have:

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.

A passion for communication; Spoken and written (full professional proficiency).

(Ideally) experience of working with the purification of API’s.

Excellent ability to plan and coordinate the writing work in line with an ambitious submission strategy.

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 across BRD to improve your knowledge and skills. The regulatory writer team consists of three regulatory writers, and we are looking for a team player that lives the whole is greater than the sum of the individual parts as we believe that teamwork divides the task but doubles the success. BRD is expanding rapidly, and the project plans are ambitious, which means that you should be able to enjoy the fast pace and be pragmatic to find the correct level in your professional tasks to live up to requirements while also supporting the business needs. 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. BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and 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 questions about the job or just want to get a feel for the department and our exciting challenges ahead, please do not hesitate to call associate manager Camilla Christensen, +45 3079 1767. Deadline 1st of May 2023. 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.