Academic for case processing of company authorisations at the Danish Medicines Agency

Do you want to contribute to Danish patients being able to trust the quality and safety of their medicines? As part of the Danish Medicines Agency you help ensure that medicines are manufactured and distributed in accordance with applicable requirements and under orderly and safe conditions. Do you have a strong natural science background, and do you thrive in case processing and professional assessments? Then you may be our new colleague in the Section for Licences and Product Defects.

At the Danish Medicines Agency we help create the framework so that citizens and the health service can have confidence in the medicines and medical devices that are used every day.

As part of the Licences team you will play a central role in dialogues with companies, you will work with a broad and varied case area, where we, among other things, issue licences for the manufacture and introduction of medicines and intermediates, wholesale and retail negotiations, as well as company registrations for manufacture, import and distribution of active substances.

In addition, we process applications and licences relating to narcotics, including import and export certificates as well as destruction licences.

With us you have the opportunity to combine your natural science expertise with regulatory work, collaboration with many different national and international stakeholders, and to continually delve into complex and society-critical issues. We are looking for an engaged academic with a start date of

• December 2026

.

Your primary tasks

Regulatory case processing: You assess, process cases, and make decisions on applications for licences to manufacture and import medicines and intermediates as well as wholesale negotiations.

Legal interpretation and practice: In collaboration with colleagues you interpret the medicines legislation and related regulations, EU regulations and guidelines to ensure consistent professional and legal decisions.

Interdisciplinary collaboration: You consult with our inspectors (who supervise the companies) and lawyers to ensure a joint exercise of authority.

Quality work: You help maintain our quality system and uphold our internal planning structure to achieve our operational goals.

Your everyday life with us

You will become part of a strong interdisciplinary community with 15 dedicated colleagues and student assistants, where we work closely in a daily life characterized by high professionalism, good camaraderie, and humor.

Your daily work will involve both internal contact within the Danish Medicines Agency and external contact with companies, trade associations, and other European medicines authorities.

During the first period you will undergo thorough training tailored to your competences and professional experience.

Everyone has an important role in our team with different professional tasks and areas of responsibility.

Your education, experience and personal qualifications

You have an academic education as a pharmacist or another natural science background.

We particularly look for you to

•

• Have experience working within GDP and GMP.
• Have understanding of the roles of the individual actors in the manufacture and distribution of medicines.
• Have knowledge of legislative processes and be able to read legislation.
• Can express yourself in both Danish and English.
• Work in a structured manner and will help develop and optimise our ways of working.
• Thrive in operational and routine tasks.
• Have good interpersonal skills and enjoy working across different disciplines.
• Have a good sense of humor and contribute to the positive atmosphere in the section.

We offer

Flexible working hours with a flexitime arrangement and the possibility of remote work by arrangement.

• Good canteen, free gym and good coffee at the office
• We have a staff association, an art association, morning songs, so that it is nice to go to work, and that we have a focus on leisure and family life
• This will be a role with independent responsibility and tasks of great societal value. You will become part of an active professional environment where, together with skilled and dedicated colleagues, you will have the opportunity to apply and develop your competences across a wide field of tasks.
• You will join an organisation with good opportunities for professional challenges, and where it is expected that the individual takes responsibility and works independently. We work cross-functionally and draw on each other''s competencies in the agency. The culture in the unit is characterised by an informal tone and a shared awareness of the importance of good collaboration in a busy everyday life.

About Companies and Control

The Licence team is part of the Unit Companies & Control. The unit's tasks include handling quality defects in medicines, applications for business licences, and control of pharmaceutical companies and medicines, among other things via inspections and analyses in our laboratory. The unit consists of 3 sections, where the Licences team is part of the Licences & Product Defects section. The section comprises about 25 employees spread over two teams and a staff function.

You will be employed under the current collective agreement between the Ministry of Finance and the Central Organisation of Academics.

At the Danish Medicines Agency we make decisions in authority cases, and it is important to us that there can be no questions about our impartiality. Therefore it is a condition that you do not own shares, part-ownership, equity or similar in a pharmaceutical and/or medical company. However you have some period to sell them if you currently own so-called employee shares in a pharmaceutical and/or medical company.

Feel free to contact us

To learn more about the position, please call Academic staff member Martine Ølgaard at 23 36 18 32 or Team Leader Fatma Schmücker Conteh at 21 49 38 91.

You can read more about us and our tasks at Lægemiddelstyrelsen.dk.

Are you interested?

Click on "apply for the position" and send us your application with CV and diploma. We expect to hold interviews in weeks 43 and 44.

Application deadline: Oct. 20