Would you like to be part of Novo Nordisk Regulatory Affairs Project organisation in Søborg? If yes, then we are seeking a Senior Associate to Regulatory Affairs Victoza® and liraglutide obesity. You will work together with a number of highly skilled and motivated people responsible for ensuring the regulatory input and support to Victoza® life cycle management as well as development projects within diabetes and obesity. We are looking for a person who enjoys structure, promptness and a dynamic environment. We offer an opportunity to work and grow within an exiting regulatory area. You will collaborate with colleagues from Novo Nordisk in Denmark as well as with affiliates.
Overall, Regulatory Affairs is responsible for obtaining and maintaining marketing authorisations worldwide. This includes interaction with Health Authorities in connection with planning of meetings, submission of clinical trial applications, submission and maintenance of marketing authorisation applications.
Challenges
Part of your everyday work will include quality check of documents for regulatory submissions, and compiling and archiving of electronic documents into our global document management system. Many regulatory applications generated by Novo Nordisk are submitted electronically. One of your tasks will be to ensure careful electronic archiving of documentation in our systems and quality checks before the application is submitted to the authorities. Thus, administrative duties and IT systems support will be part of your everyday task. We work with several very different submissions and thus you need to be able to joggle several tasks at the same time. You will be point of contact for our colleagues’ in other countries and assist them among others with different certificates, product samples and submission support. Furthermore, you will have close interaction with many different departments within Novo Nordisk in Denmark.
You will be member of a global regulatory team (GRT) headed by a regulatory project manager and work to achieve the ambitious goals of the project. You will be responsible for preparation of internal meetings and writing minutes.
This requires good coordination and planning skills, accountability and the ability to work under tight deadlines including high work loads in periods. Your duties include supporting the regulatory project manager and members of the GRT as appropriate, a.o. through contributing to and participating in project team meetings. You will be a key player in keeping track of timelines and deliverables. You will also be responsible for keeping up to date with current internal and external requirements within area of responsibility.
Qualifications
You have a relevant educational background, as minimum a bachelor’s degree in science, business administration or English. You must have administrative experience from regulatory affairs or related fields in the pharmaceutical industry. You have experience with professional use of IT systems such as electronic document management and are proficient in the Microsoft Office package. You are proactive and like to work independently, as well as in a team. You are flexible, are able to work under tight deadlines, have a strong quality mindset and a sense for details, good coordination and planning skills and an excellent command of written and spoken English.
Contact
For further information, please contact Lene Melchiorsen at +45 3075 1993 or Christina Buhl Duvier at +45 3079 1136.
