Regulatory Professional
- Regulatory Affairs
- Denmark - Søborg
In Regulatory Affiliate Support, we are looking for a Regulatory Professional to join a dedicated group of people working closely together with Novo Nordisk A/S affiliates worldwide, Regulatory Affairs product/project groups in headquarters in Denmark and with the Regulatory Affairs Operations Team in India.
About the department
Regulatory Affiliate Support is part of Regulatory Operations within Regulatory Affairs, which makes medicine available to patients all over the world by ensuring rapid regulatory approval in all markets. Regulatory Affairs is a fast-changing field, and the 330 employees serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.
You will be part of a team consisting of 14 people situated in Søborg, Denmark providing support and services across Novo Nordisk A/S projects and products.
The Job
In Regulatory Affiliate Support we are responsible for supplying Novo Nordisk A/S affiliates and product/project groups with additional registration file documentation for submissions to health authorities worldwide.
As Regulatory Professional, you will be the central point of contact for Novo Nordisk A/S affiliates. Your primary task will be to support with additional documentation such as samples, certificates and statements, and you will also be responsible for documenting deviations from procedures. Furthermore, management of IT systems to ensure precise updates of our product portfolio in collaboration with the Regulatory Operations Team in India will also be part of the job.
Coordinating and supporting internal stakeholders such as Product Supply, Quality and Logistics supporting with regulatory knowledge will also be your responsibility. New requirements constantly emerge within the regulatory area; therefore, the position includes possibilities for project work to identify solutions to such new reqirements as well as continuous process optimization activities.
Qualifications
You have a relevant degree within science/pharmacy/medicine or business/ marketing, preferably with a strong business orientation; and you have at least 3 years experience from similar positions. Experience from the pharmaceutical industry and within regulatory affairs will be an advantage.
We expect that you are able to drive activities and tasks independently and systematically with an eye for detail and high quality output as we often work with tight deadlines. You are able to stay on target and manage multiple assignments without loosing track. You posses good analytical skills and problem solving abilities and address your responsibilities with decisiveness and a positive mind set.
You have advanced communication skills and have the experience with presenting in large forums as stakeholder management and communication are essential for succeeding in the job. Furthermore, we expect that you possess strong cross-cultural skills and are used to working with international business partners. Finally, you must be fluent in written and spoken English.
In Novo Nordisk A/S it is your skills, your commitment and your ambitions which help us to improve many people’s lives. In return we offer you the opportunity to work with talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Tina Lindquist at +45 3075 9652 or Pil Elisabeth Mortensen at +45 3079 0635.
Deadline
12 January 2014.
- Regulatory Affairs
- Denmark - Søborg
In Regulatory Affiliate Support, we are looking for a Regulatory Professional to join a dedicated group of people working closely together with Novo Nordisk A/S affiliates worldwide, Regulatory Affairs product/project groups in headquarters in Denmark and with the Regulatory Affairs Operations Team in India.
About the department
Regulatory Affiliate Support is part of Regulatory Operations within Regulatory Affairs, which makes medicine available to patients all over the world by ensuring rapid regulatory approval in all markets. Regulatory Affairs is a fast-changing field, and the 330 employees serve as Novo Nordisk’s advocates around the world – and make a meaningful difference to our business.
You will be part of a team consisting of 14 people situated in Søborg, Denmark providing support and services across Novo Nordisk A/S projects and products.
The Job
In Regulatory Affiliate Support we are responsible for supplying Novo Nordisk A/S affiliates and product/project groups with additional registration file documentation for submissions to health authorities worldwide.
As Regulatory Professional, you will be the central point of contact for Novo Nordisk A/S affiliates. Your primary task will be to support with additional documentation such as samples, certificates and statements, and you will also be responsible for documenting deviations from procedures. Furthermore, management of IT systems to ensure precise updates of our product portfolio in collaboration with the Regulatory Operations Team in India will also be part of the job.
Coordinating and supporting internal stakeholders such as Product Supply, Quality and Logistics supporting with regulatory knowledge will also be your responsibility. New requirements constantly emerge within the regulatory area; therefore, the position includes possibilities for project work to identify solutions to such new reqirements as well as continuous process optimization activities.
Qualifications
You have a relevant degree within science/pharmacy/medicine or business/ marketing, preferably with a strong business orientation; and you have at least 3 years experience from similar positions. Experience from the pharmaceutical industry and within regulatory affairs will be an advantage.
We expect that you are able to drive activities and tasks independently and systematically with an eye for detail and high quality output as we often work with tight deadlines. You are able to stay on target and manage multiple assignments without loosing track. You posses good analytical skills and problem solving abilities and address your responsibilities with decisiveness and a positive mind set.
You have advanced communication skills and have the experience with presenting in large forums as stakeholder management and communication are essential for succeeding in the job. Furthermore, we expect that you possess strong cross-cultural skills and are used to working with international business partners. Finally, you must be fluent in written and spoken English.
In Novo Nordisk A/S it is your skills, your commitment and your ambitions which help us to improve many people’s lives. In return we offer you the opportunity to work with talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Contact
For further information, please contact Tina Lindquist at +45 3075 9652 or Pil Elisabeth Mortensen at +45 3079 0635.
Deadline
12 January 2014.