Associate Analyst for Submission Management Regulatory Affairs
Are you a service minded and have a can-do attitude with continuous improvement as one of your career objectives? Join Regulatory Operations in the Global Service Centre (GSC) at Novo Nordisk and get a life-changing career.
About the department
The GSC Submission Management department was established in 2010, with a purpose of delivering high quality registration dossiers to our affiliates worldwide.
The focus area of our department is to provide a superior service to our stakeholders consistently and add value to our submission processes in terms of standardisation and efficiency.
As Regulatory affairs (RA) Associate Analyst, you will be responsible for compiling and publishing the submission of Marketing Authorisation Application (MAA)/Life cycle Management application to European Health Authorities. Your key responsibilities are facilitation of submission planning meetings with RA colleagues from product portfolio as well as submission management coordinator from Regulatory Affairs at headquarters (RAHQ) Denmark, compilation of dossier based on Table of Contents (TOCs) provided by RA HQ in Electronic Common Technical Document (eCTD) format, publishing the dossier & perform post publishing activities, add navigation elements like hyperlinks, bookmarks, perform validation of submission and upload submission in European Medicines Agency (EMA) Gateway.
You will be delivering high quality registration dossiers, which require a good understanding of regulatory guidelines, administrative, Chemistry, Manufacturing and Control (CMC), non-clinical & clinical documentation, different registration file formats (centralised procedure, mutual recognition procedure, decentralised procedure & national procedure for European Union (EU)) and the regulatory dossier publishing process. Hands on experience in publishing tools like Lorenz Docubridge, Liquent Insight, ISI Publishing, ISI Tool Box, Adobe Acrobat, etc. Hands on experience in validation tool like EURS, Lorenz, etc. Experience in xml editing & Document Management system is preferable. Exposure to e-submission gateways are mandatory.
The job involves close collaboration with global regulatory teams in Denmark, as well as Novo Nordisk affiliates across the EU to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role. Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority.
Our organisation is dynamic, with change management being an essential part of our everyday life. In addition, there is a constant focus on optimising our working processes and you will be involved in cross functional improvement activities.
You have a Post Graduate education in Science (e.g. Master of Pharmacy, Biotechnology, Medicinal Chemistry, Life sciences) and experience in working with Regulatory Affairs. You should have at least 5 years of experience and at least 2 years of relevant experience in handling eCTD/NeeS/National format dossier especially for EU countries. You should have strong IT system knowledge for Regulatory dossier publishing.
As a person, you thrive in a busy environment and you bring a can-do attitude. You’re a strong team player, but you also enjoy working independently. You are a skilled communicator, who can collaborate with a lot of stakeholders and comfortable using your excellent written and spoken English proficiency on a daily basis.
Furthermore, you have flair for IT systems and experience with MS Office. We expect you to be a good planner, well organised, service minded, positive, engaged and actively contribute to a good team spirit.
Working at Novo Nordisk
At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. In exchange, we offer you the opportunity to work with extraordinary talent globally and benefit from a range of possibilities for professional and personal development.
1 April 2019.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.