Work with us

Are you a senior regulatory expert in
chemistry, manufacturing
and control (CMC)?

Would you like to use your knowledge to help drug development companies navigate the regulatory landscape? If you also like to work in a team-oriented and supportive environment together with other senior experts, this may be your next job!

RegSmart is a regulatory consultancy firm with a solid foundation in science and with extensive regulatory experience. Our aim is to facilitate the drug and medical device development process for Life Science companies.

As senior consultant at RegSmart you will engage with a wide variety of clients, projects and assignments. Some examples of possible responsibilities are listed below:

• Develop a short/long-term regulatory CMC strategy for development of a drug product or drug-device combination product including e.g control strategy, starting material strategy, change strategy.
• Provide regulatory advice in pharmaceutical development activities such as specification setting, stability program design and analytical testing.
• Clarify quality requirements in different product development phases.
• Write/review regulatory documentation such as briefing documents, investigational medicinal product dossiers (IMPDs)/investigational new drug (IND) applications, and market authorization applications (MAA)/new drug application (NDA).
• Arrange and participate in meetings with competent authorities.
• Provide project management for CMC activities.

Qualification requirements:

To succeed as a senior consultant at RegSmart you need to be able to share your expertise and experience with the clients in a way that works for them. You should also be able to handle several different projects/clients in parallel.

An academic degree in a relevant scientific area and a professional level of English is required.

Further, we want you to have solid regulatory experience from working at a regulatory agency and/or a drug development company with biological, ATMP and/or small molecule synthetic drugs and expertise in one or more of the following areas:

• Drug substance process development
• Formulation development
• Drug-device combination products
• EU/US regulations
• Sterile preparations
• Analytical development

To enjoy your work at RegSmart, we think that you are science-driven, good at expressing your opinions with the recipient in mind, as well as interested in finding effective solutions to our clients’ needs.

About RegSmart:

We are a great team of experts who use our collective experience in regulatory affairs to make a difference in every project. Take a look at our staff: https://regsmart.se/board/

We are located at Eklundshovsvägen 5 in Uppsala, with possibilities to work either at the office or remote.

We offer competitive terms and are flexible when it comes to starting date and working hours.

Don´t hesitate to contact us if you have any questions.

Submit your application to:

Agneta Larhed
mail: agneta.larhed@regsmart.se
phone: +46 (0) 72-74 67 350