Regulatory Submission Coordinator - Regulatory Clinical, Non-Clinical & Operations

Do you have an interest in Regulatory Affairs and experience in working with regulatory submissions? Do you want to be part of a team who is involved in both development activities as well as lifecycle activities and who support each other to reach the goals in a busy everyday life? Do you have an eye for details but also capable of seeing the bigger picture?

Position
As Regulatory Affairs Coordinator you will be given a range of responsibilities within regulatory affairs. You will have a combination of administrative and regulatory tasks.

In this role you will among others:

• In collaboration with the team members establish, compile and coordinate the administrative, non-clinical and clinical parts of regulatory submissions for products in different regions working in the document management systems Veeva RIM.
• Be responsible for regulatory e-submission activities for different ALK products and be the contact to the external vendor.
• Collaborate with stakeholders both in- and outside Global Regulatory Affairs.
• Handle different administrative tasks, certificates, payments etc.
• Participate in submission teams.
• Coordinate label activities for ALK's products.
• Take part in writing and updating quality management systems, e.g. work instructions.

Your qualifications
We expect you to have a technical education e.g. farmakonom or similar relevant education preferably combined with experience from the pharmaceutical industry. It will be an advantage if you have experience in e-submissions, document management systems e.g. Veeva and from working in a global regulatory affairs department. Having experience in centralized EU regulatory procedures is a benefit.

In order to be a success in this role, we seek a person who is naturally pragmatic. You take on responsibility for having the job done and being well-structured and organized. You are comfortable communicating in English both orally and in writing and you are proactive, service-minded and a profound team-player.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialized in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work in our office in Hørsholm but we also provide a degree of flexibility to work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 10 June 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at [xxxxx] For further information regarding the position please contact Director, Lotte Bruun Christiansen on +[xxxxx].

We are looking forward to hearing from you!