Regulatory Affairs Professional, CMC

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.

GRA counts approximately 50 people and we are located in Hørsholm.

Position

As Regulatory Affairs Professional you will be given a range of responsibilities within regulatory CMC activities in ALK.  You will work closely together with top motivated team members. The team consists of 12 people including the manager of the team.

Furthermore, you will be involved in:

• Collaboration with stakeholders both in- and outside GRA on CMC regulatory activities for different ALK products.
• Establishment, compilation and coordination of the CMC part of regulatory submissions for new Marketing Authorization Applications as well as life cycle management activities for ALK products in different regions, e.g. Europe and MENA
• 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

What you bring

We expect you to have a Masters Degree within a relevant field (e.g. pharmacy, engineering), preferably combined with experience from the pharmaceutical industry/ life science.

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.

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 Lone Rønnemoes Pedersen on telephone: +45 2566 4085

How to apply

Please click on apply and kindly remember to attach a letter of motivation and CV. Application deadline is 20.08.2021 and we evaluate applications on an ongoing basis.

We are looking forward to hearing from you.