Join a team of highly-skilled Regulatory Affairs Professionals for 12 months
ALK offers an exciting opportunity to work in their 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.
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 of the RA-team. The team consists of 9 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 ALK´s SLIT-tablets
- In collaboration with other functional areas in ALK, establishment, compilation and coordination of the administrative, non-clinical and clinical part of regulatory submissions for ALK´s SLIT-tablets in different regions
- Participation in partner activities and meetings
- Coordinate label activities for ALK's SLIT-tablets.
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 with a strategic mindset who is naturally pragmatic and who sees solutions instead of problems. You also need to be a skilled communicator, with the ability to interact on a professional level with the regulatory authorities.
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 Mette Schou-Hanssen on telephone: +45 61 91 11 78.
How to apply
Please click on apply and kindly remember to attach a letter of motivation and CV. Application deadline is March 12 and we evaluate applications on an ongoing basis. We are looking forward to hearing from you.