Regulatory Affairs Professional – temporary position
Denne stilling er desværre ikke længere ledig.
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Hørsholm
Join a team of highly-skilled Regulatory Affairs Professionals for 12 months
ALK offers an exciting opportunity to work in the Global Regulatory Affairs (GRA) department with lots of interdisciplinary collaboration both internally and externally. GRA counts approximately 50 people and we are located in Hørsholm.
The position
As Regulatory Affairs Professional you will be given a range of responsibilities within both regulatory clinical, non-clinical and procedural activities in ALK. You will work closely together with the top motivated team members. The team consists of 11 people including the manager of the team.
Furthermore, you will be involved in:
What you bring
We expect you to have a Master’s Degree within a relevant field (e.g. pharmacy, engineering). In order to be a success in this role, we seek a person who is naturally pragmatic and who sees solutions instead of problems. You should have a structured approach in your daily work and be able to prepare clear and logically organised written material. You are proactive, service-minded and a profound team-player. Furthermore, you possess excellent communication skills, and you master English at a high professional level.
Become a part of ALK
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The result of your efforts will be significant throughout the organization, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
If you want to know more about the position, before submitting your application, please don´t hesitate to contact Lotte Bruun Christiansen on telephone: +45 41 90 44 69.
We are looking forward to hearing from you.
ALK offers an exciting opportunity to work in the Global Regulatory Affairs (GRA) department with lots of interdisciplinary collaboration both internally and externally. GRA counts approximately 50 people and we are located in Hørsholm.
The position
As Regulatory Affairs Professional you will be given a range of responsibilities within both regulatory clinical, non-clinical and procedural activities in ALK. You will work closely together with the top motivated team members. The team consists of 11 people including the manager of the team.
Furthermore, you will be involved in:
- Collaboration with stakeholders both in- and outside GRA on non-clinical, clinical and procedural regulatory activities for different ALK products
- Support establishment, compilation and coordination of the administrative, non-clinical and clinical part of regulatory submissions for ALK products in different regions, e.g. Europe and MENA
- Handling of system for evaluation of changes to printed packaging material
- Update and maintenance of Summary of Product Characteristics (SmPCs), Package leaflets (PLs) and Printed Packaging Material
- Writing and updating quality management systems, e.g. work instructions
What you bring
We expect you to have a Master’s Degree within a relevant field (e.g. pharmacy, engineering). In order to be a success in this role, we seek a person who is naturally pragmatic and who sees solutions instead of problems. You should have a structured approach in your daily work and be able to prepare clear and logically organised written material. You are proactive, service-minded and a profound team-player. Furthermore, you possess excellent communication skills, and you master English at a high professional level.
Become a part of ALK
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The result of your efforts will be significant throughout the organization, and you will be able to actively influence and challenge the status quo. The flat structures in ALK attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
If you want to know more about the position, before submitting your application, please don´t hesitate to contact Lotte Bruun Christiansen on telephone: +45 41 90 44 69.
We are looking forward to hearing from you.
Information og data
Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 15.1.2020, 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.
- Laborant
- Hørsholm
- Mandag den 07. december 2020
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