Pharmaceutical Investigator at the Swedish Medical Products Agency

At the Swedish Medical Products Agency, we make a difference together. In life and for life. We work for the health of people and animals, for a better Sweden today and in the future. Do you have knowledge of drug development and want to contribute to our important mission? Then this could be something for you.

Our Operations

The Regulatory Affairs Department works in several ways to ensure that appropriate medicines reach patients. Approvals of new medicines, safety monitoring, and management of changes to approved products are central parts of our mission, as well as providing advice regarding drug development and information about medicines. The Regulatory Affairs Department has over 300 employees and consists of several units, where we who work in the Unit for Pharmacy and Biotechnology (FoB) evaluate the pharmaceutical quality of medicines. This includes evaluating documentation regarding the development, manufacturing, characterization, and control of medicines throughout their lifecycle. The evaluation forms an important basis for the decision on whether a medicine can be approved for clinical use. We collaborate with other EU member states and actively contribute to committees and working groups within the European Medicines Agency (EMA). The unit also participates in efforts to assist companies and researchers with scientific advice, as well as in the development of guidelines within the framework of international normative cooperation.

Your Responsibilities

Your main task as an investigator is to critically assess the pharmaceutical quality of medicines based on the documentation submitted with the drug application, in accordance with regulatory requirements, guidelines, and legal regulations, as well as from a scientific perspective. This includes both the active pharmaceutical ingredient and the medicinal product. The investigation work includes assessments in the areas of organic chemistry, physical chemistry, analytical chemistry, pharmaceutical formulation, and biopharmaceutics. The assessments result in an investigation report.

Within the area of responsibility, both medicines containing new active substances and generic products are included. The work is independent and developmental. It involves close collaboration with colleagues within the agency as well as with other regulatory authorities within the EU.

Your Background

We are looking for someone who is a pharmacist, chemist, engineer, or has a comparable educational background. You have several years of experience and knowledge of pharmaceutical development and/or manufacturing. The daily work requires good computer skills as well as a good ability to communicate in both spoken and written Swedish and English.

Desirable qualifications for the position include:

• PhD in a relevant field
• Experience in the manufacturing and development of solid and/or semi-solid formulations such as tablets, creams, and gels
• Knowledge of physicochemical characterization of relevant product types, for example using rheological methods
• Experience from working in the pharmaceutical industry
• Experience from working with pharmaceutical regulatory documentation.

Your Personal Qualities

You have a scientific mindset and a good ability to see connections in large amounts of information, extract the essential, and describe, evaluate, and justify your conclusions. You are meticulous and have a good ability to work methodically and systematically while maintaining the quality and productivity that the role requires. You work independently, act with integrity, and are responsible. You have a good ability to plan and organize your work and to work purposefully towards established deadlines. You have a solution-focused approach and actively work for good relationships and shared results.

We place great importance on personal qualities.

Good to Know

Application deadline: 2025-04-22
Employment type: Permanent
Start date: By agreement
Unit: Pharmacy and Biotechnology
Diary number: 2.4.1-2025-021341

We apply a 6-month probationary period. We value diversity and welcome applicants with different backgrounds.

At the Swedish Medical Products Agency, you will have good conditions for work-life balance. We offer you, among other things, flexible hours, favorable vacation conditions, wellness benefits, and wellness during working hours. To the extent that the tasks allow, there is the possibility to work partially remotely by agreement with the manager.

Read more about the benefits you receive with us here: Benefits with us (https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss)

The Swedish Medical Products Agency is a preparedness authority, which means that we conduct certain background checks in connection with recruitments. You will need to verify your identity and present your diploma and relevant certificates during a possible interview. All permanent staff at the Swedish Medical Products Agency are assigned to military service within the agency.

Contact

You are welcome to contact group manager Patrik Samuelson. You can also contact the union representatives Alexandra Braf, Saco, and Pia Wictor, ST. We can all be reached at phone number 018-17 46 00 or by email firstname.lastname@lakemedelsverket.se.

More about the Swedish Medical Products Agency

You may not think about the Swedish Medical Products Agency very often, but we can promise that you encounter us in your daily life. The results of what we do are visible at pharmacies, hospitals, at the veterinarian, and in your bathroom cabinet. We ensure that you and everyone else in Sweden have access to safe and effective medicines and medical devices, from band-aids and pregnancy tests to walkers and apps. We do this by approving and granting permits, monitoring and controlling, and by informing and advising. We who work at the Swedish Medical Products Agency are proud of our important societal mission: to contribute to the health of the Swedish population and animals.

Read more about our mission and what it means to work at the Swedish Medical Products Agency here: Our Mission (https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket)

Welcome with your application! This recruitment is conducted entirely by the Swedish Medical Products Agency. Therefore, we kindly ask recruitment companies and advertisement sellers not to call us.