Two Regulatory Affairs Professionals

Two Regulatory Affairs Professionals

ALK

 Join a global, dynamic pharmaceutical company where your contributions will have a significant impact!

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 internally and externally. You will work closely together with top motivated colleagues. GRA counts approximately 50 people and is located in Hørsholm.

Position within Regulatory CMC

As Regulatory Affairs Professional, you will be given a range of responsibilities within regulatory CMC activities covering Adrenalin containing products in ALK.

Furthermore, you will be involved in:

  • Collaboration with stakeholders both in- and outside GRA on CMC regulatory activities.
  • Establishment, compilation, and coordination of the CMC part of regulatory submissions for new Marketing Authorization Applications as well as life cycle management activities for Adrenaline containing ALK products in different regions, e.g. EU, MENA, UK.
  • Writing CTD sections for module 3 based on source documents from subject matter experts.
  • Writing and updating quality management documents, e.g. work instructions for regulatory activities.

Position within Regulatory Clinical/Non-clinical

As Regulatory Affairs Professional, you will be given a range of responsibilities within both regulatory clinical, non-clinical and procedural activities covering Adrenalin containing products in ALK.

Furthermore, you will be involved in:

  • Collaboration with stakeholders both in- and outside GRA on non-clinical, clinical, and procedural regulatory activities.
  • In collaboration with other functional areas in ALK, establishment, compilation, and coordination of the administrative, non-clinical and clinical part of regulatory submissions for new Marketing Authorisation Applications as well as life cycle management activities for adrenaline containing ALK products in different regions, e.g. EU, Asia, MENA, UK.
  • Update and maintenance of Summary of Product Characteristics (SmPCs), Package leaflets (PLs) and Printed Packaging Material.
  • Writing and updating quality management documents, e.g. work instructions.

What you bring

We expect you to have a master’s degree within a relevant field (e.g. pharmacy, engineering), preferably combined with experience from the pharmaceutical industry/life science within Pharma, Devices and/or Drug/device combination product. 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 should have a structured approach in your daily work and be able to prepare clear and logically organized written material on complex matters. 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. Finally, you have a healthy sense of humour.

Would you like to know more?

The recruitment process is carried out in collaboration with the consulting company Compass Human Re-sources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Senior Research Consultant, Pernille Hemmingsen at +45 70 20 12 75. Please submit you application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

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.

Deadline for application: As soon as possible
Workplace: 
Hørsholm
Reference: 
2105.333
Company: 
ALK