Regulatory Affairs Professional - 2 open positions

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Hørsholm

Join a team of highly-skilled Regulatory Affairs Professionals

ALK offers an exciting opportunity to work in the Global Regulatory Affairs (GRA) department with lots of interdisciplinary collaboration both internal and external. GRA counts approximately 55 people and we are located in Hørsholm.

Position

As 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. We have 2 open positions in 2 different teams. In 2022 Global Regulatory Affairs will implement a new cloud-based document management system which will require a lot of new ways of working for all of us.

Furthermore, you will be involved in:

  • Collaboration with stakeholders both in- and outside GRA on nonclinical, clinical and procedural regulatory activities for ALK´s products
  • In collaboration with other functional areas in ALK, establishment, compilation and coordination of the administrative, nonclinical and clinical part of regulatory submissions for ALK´s products in different regions
  • Submission of new marketing authorisation applications as well as maintenance activities

  • Participation in partner activities and meetings
  • Coordinate label activities

What you bring

We expect you to have a master degree within a relevant field (e.g. pharmacy, engineering), preferable combined with experience from the pharmaceutical industry, medical device or diagnostics. Furthermore, if you have previously worked with global regulatory affairs this will be an advantage.

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 are proactive, positive 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 positions, before submitting your application, please don´t hesitate to contact manager Lotte Bruun Christiansen, telephone +45 41904469 or manager Mette Schou-Hanssen, telephone: +45 61911178.

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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 3.11.2021, 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 11. december 2021

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