Principal Regulatory Affairs Professional
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Hørsholm
Are you willing to challenge the status quo and embark on a transformational journey in a pharma company with an ambitious growth target in the years to come? Do you like strategy while keeping an eye on operational excellence? Do you have experience in working within Regulatory Affairs and would you like to be Global Regulatory Lead for an assigned product?
As a Principal Regulatory Affairs Professional you will be given a range of responsibilities within regulatory clinical, nonclinical and procedural activities in ALK. You will work closely together with top motivated team members. You will be Global Regulatory Lead for one of our tablet products as well as being support to other projects. We are a team of 11 highly skilled regulatory professionals.
Fields of responsibility
Your qualifications
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organisation and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organisation and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
Application deadline is September 7th and we will evaluate applications on an ongoing basis.
Contact
For further information on the position please contact Regulatory Affairs Director Mette Schou-Hanssen on telephone: +45 6191 1178.
As a Principal Regulatory Affairs Professional you will be given a range of responsibilities within regulatory clinical, nonclinical and procedural activities in ALK. You will work closely together with top motivated team members. You will be Global Regulatory Lead for one of our tablet products as well as being support to other projects. We are a team of 11 highly skilled regulatory professionals.
Fields of responsibility
- Global Regulatory Lead for an assigned product
- Establish, compile and coordinate the administrative, nonclinical and clinical part of our regulatory submissions in different regions for market expansions, indication extensions and life-cycle management
- Collaborate with stakeholders both in- and outside global regulatory affairs on nonclinical, clinical and procedural regulatory activities for assigned product and projects
- Being up-to-date with regional regulations and guidelines
- Support to audits, writing and reviewing our SOPs, and maintenance of our newly implemented cloud-based regulatory information and document management system
Your qualifications
- You are pragmatic and sees solutions instead of problems
- You are proactive, positive and a profound team player
- You have a master degree within a relevant field (e.g. pharmacy, engineering)
- Preferably you have of experience from the pharmaceutical industry, medical device or diagnostics
- Experience from a global regulatory affairs department will be an advantage
- You possess excellent communication skills and master English at a high professional level
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organisation and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organisation and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
Application deadline is September 7th and we will evaluate applications on an ongoing basis.
Contact
For further information on the position please contact Regulatory Affairs Director Mette Schou-Hanssen on telephone: +45 6191 1178.
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 31.3.2020, 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
- Lørdag den 09. juli 2022
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