Regultory professional
- Regulatory Affairs
- Denmark - Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.We are currently looking for 2 new regulatory professionals with an interest in CMC to join our team with a product portfolio within the Insulins and Oral Proteins.
About this department
In Regulatory Affairs, you willl work in a fast-paced environment where not two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You will be expected to make an impact, to ask questions and challenge the status quo, if that is what it takes. The department consists of 2 teams.
The job
Our team handles tasks within the Regulatory Affairs CMC area to ensure succesfull lifecycle management of our marketed insulin products as well as our Clinical Trial Applications. Our team consists of 18 employees, and we are located in Søborg. Resently, the team has implemented a new way of working – where products are handled in product groups covering the products from cradle to grave. Our team is constantly focusing on knowledgesharing and being a
high-performing team.
The CMC Insulins and Oral Proteins offer many challenges, and you can expect to spend a considerable amount of time working with both regulatory submissions and regulatory support/stragies in close collaboration with stakeholders and our affiliates from all over the world. Our department has set a goal: We want to be RA CMC Champions – finding the key for this is a process you are expected to be highly involved in! – Being a part of our team will mean a daily life where you are to handle a broad portfolio of tasks, and you need to thrive with both big demanding projects and minor tasks –teamspirit is key!
Qualifications
We expect you to have a university degree in science and documented professional experience working with regulatory affairs and/or the pharma industry. The candidate should have experience within production, from QA or from Regulatory Affairs, and it is preferred that you are familiar with CMC details for both the Drug Substance and the Drug Product part of the regulatory file. One of the positions will require a strong knowledge within the Oral Drugs area.
As a person, you thrive in a busy environments and bring a can-do spirit and a healthy sense of humour to your work, even when the pressure is on. You are a strong team player contributing to the team both scientifically and socially.You also enjoy working independently on your own projects and challenge the status quo to find new solutions to the challenges you meet - in short a “Can-do” attitude!
You are a skilled communicator who is comfortable speaking and writing in English. This portfolio of competencies are needed in our daily work with our many different stakeholders – from the production area to direct contact with Health Authorities.
In Novo Nordisk is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Lene Vindelev on +45 3075 3358. In week 30 – 32 kindly contact Philip Avnstrøm on +45 3075 0586.
Deadline
14 August 2013.
- Regulatory Affairs
- Denmark - Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.We are currently looking for 2 new regulatory professionals with an interest in CMC to join our team with a product portfolio within the Insulins and Oral Proteins.
About this department
In Regulatory Affairs, you willl work in a fast-paced environment where not two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You will be expected to make an impact, to ask questions and challenge the status quo, if that is what it takes. The department consists of 2 teams.
The job
Our team handles tasks within the Regulatory Affairs CMC area to ensure succesfull lifecycle management of our marketed insulin products as well as our Clinical Trial Applications. Our team consists of 18 employees, and we are located in Søborg. Resently, the team has implemented a new way of working – where products are handled in product groups covering the products from cradle to grave. Our team is constantly focusing on knowledgesharing and being a
high-performing team.
The CMC Insulins and Oral Proteins offer many challenges, and you can expect to spend a considerable amount of time working with both regulatory submissions and regulatory support/stragies in close collaboration with stakeholders and our affiliates from all over the world. Our department has set a goal: We want to be RA CMC Champions – finding the key for this is a process you are expected to be highly involved in! – Being a part of our team will mean a daily life where you are to handle a broad portfolio of tasks, and you need to thrive with both big demanding projects and minor tasks –teamspirit is key!
Qualifications
We expect you to have a university degree in science and documented professional experience working with regulatory affairs and/or the pharma industry. The candidate should have experience within production, from QA or from Regulatory Affairs, and it is preferred that you are familiar with CMC details for both the Drug Substance and the Drug Product part of the regulatory file. One of the positions will require a strong knowledge within the Oral Drugs area.
As a person, you thrive in a busy environments and bring a can-do spirit and a healthy sense of humour to your work, even when the pressure is on. You are a strong team player contributing to the team both scientifically and socially.You also enjoy working independently on your own projects and challenge the status quo to find new solutions to the challenges you meet - in short a “Can-do” attitude!
You are a skilled communicator who is comfortable speaking and writing in English. This portfolio of competencies are needed in our daily work with our many different stakeholders – from the production area to direct contact with Health Authorities.
In Novo Nordisk is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Lene Vindelev on +45 3075 3358. In week 30 – 32 kindly contact Philip Avnstrøm on +45 3075 0586.
Deadline
14 August 2013.