Senior Regulatory Associate
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Søborg
- Regulatory
- Søborg
Does being a part of changing the lives of millions of people sound appealing to you? It does to us. Would you like to be part of our Global Regulatory Affairs department (RA) and contribute to its success? If so, RA-Biopharm 2, has an exciting opportunity for you as a Senior Regulatory Associate. Regulatory Affairs is a fast-changing field where no two days are alike, and the engaged employees in our unit need a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders. That makes RA a truly interesting and challenging place to work.
About the department
The department “RA Biopharm 2” is part of RA Biopharm in Regulatory Affairs and is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg.
We are a group of highly skilled and dedicated people involved in every clinical and non-clinical aspects concerning marketed products as well as projects in development within Haemophilia and Growth Hormone disorders. The project portfolio is developing and in order to be able to handle the tasks and challenges within our area of responsibility we are looking for one more colleague for the department.
You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for submissions and is responsible for interactions with regulatory authorities.
The position
Being a Senior Regulatory Associate, you will be administratively responsible for planning, preparation, submission and approvals of high-quality clinical trial applications, marketing authorisation applications, variation applications, IND and NDA annual reports, Development Safety Update Report (DSUR) / Periodic Safety Update Report (PSURs) / Periodic Benefit Risk Evaluation Report (PBRERs) and Q&A documents. You will also be responsible for supporting the compilation of scientific documentation around new and existing products in accordance with internal requirements and external regulatory guidelines and regulations. You have to ensure regulatory compliance and tracking by using relevant IT systems at Novo Nordisk including filing, updating and tracking of key data in the relevant systems. You will collaborate with many stakeholders and affiliates around the world to support the progress of key regulatory activities on a daily basis.
You will work in a fast-paced environment with tight deadlines and with several competing priorities. You will be supported by a team of friendly colleagues who will be ready to help you.
Qualifications
You have some years of experience from working in Regulatory Affairs. You preferably have an educational background as Pharmaconomist, Medical Secretary, Bachelor in Science, Marketing, English or similar. You have a flair for IT systems and experience with MS Office applications as you will be responsible for managing data entry and electronic filing in our various databases and document management systems.
You pay attention to details while maintaining the big picture and clear focus. You are a structured, organised, a proactive problem-solver and have a can-do attitude. Your strong communication skills and your good-tempered approach to people make it easy for you to build and maintain trustful relations both within your department and with all the different stakeholders you will be working with. You are comfortable speaking and writing in English and preferably also in Danish. You can work independently, but you are also the team player who helps and cares about your colleagues and contributes to the good atmosphere in our department.
Should you wish to learn more about what working at Novo Nordisk is like, this is a good place to begin: novonordisk.com/careers/working-at-novo-nordisk.html
Working at Novo Nordisk
At Novo Nordisk we strive for excellence. As a world leader in diabetes care and a major player in haemostasis and hormone replacement therapy, we are proud to make a difference for millions of people around the world. We know that results are made together, and that great opportunities for personal and professional growth are important to provide.
Contact
If you have questions about the position, you are welcome to contact Henriette Sølver Schou +45 3075 1807 or Jane Møll Pedersen + 45 3075 3759.
Deadline
30 June 2019, however applications will be read on an on-going basis.
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.
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 13.6.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktchef
- Søborg
- Søndag den 30. juni 2019
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