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We are a regulatory consultancy firm that will help you navigate in a complex and evolving regulatory landscape. With our long regulatory experience from senior positions at a regulatory agency and from small and big life science companies we facilitate your work by knowing what to do, when and how.

Our mission is to create fit-for-purpose and scientifically sound regulatory strategies for drug development & medtech projects.

You provide regulatory advice and operational support to our clients' drug development projects. Usually you work with more than one client and project at a time. Here are some examples:

• 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, bridging strategy, change strategy.
• Provide regulatory advice in chemistry and pharmaceutical development activities such as selection of starting materials,  and formulation, specification setting, stability program design and establishment of re-test and shelf life.
• 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 applications (NDA/BLA).
• Arrange and participate in meetings with competent authorities.
• Provide project management for CMC activities, including to engage with CRO/CMOs.

There are no ordinary days, but common components are video or telephone meetings with clients, thinking about and discussing regulatory strategies, looking up facts, reviewing scientific reports and writing and reviewing regulatory documents. The work may also include project management and coordination. One of the perks of being a consultant is the varying nature of the projects and clients and the different challenges you'll meet. Another is to manage your own time and resources.

You can work from our office in Uppsala or partly from home.

The consultants at RegSmart come from different backgrounds. What we have in common is a passion for science and continuously developing & sharing our expertise. As Senior Consultant within regulatory CMC you will benefit from:

• A scientific background and a good understanding of the challenges small and medium sized companies are facing.
• Experience from drug development within a company in development phase, taking active part in regulatory processes.
• Experience from working in a GxP environment
• Work experience from regulatory CMC from a regulatory authority, a pharma development company or a consultancy.

Hi Agneta, what is your role at RegSmart

Hi! I'm one of the founders and Managers at RegSmart. The consultants within regulatory CMC report to me. I also work actively with our client's projects as a Senior Consultant and interim manager.

What is your background?

I'm a pharmacist and PhD with long experience from drug development at different companies and from the Swedish Medical Product Agency. My own specialty is within regulatory CMC, especially formulation development.

Who will be the ideal candidate for this job?

Someone with a scientific background and regulatory knowledge who values collaboration and communication. For this position, we need someone with senior level of experience from regulatory CMC within drug development. It could be from working at a medical product agency, in a small or larger drug developing company, for example.

What kind of manager are you?

Collaborative, we work together. I like direct, open communication and we help each other when we meet challenges.

From a Senior Consultant, I'd expect a high level of independence. At the same time, many project are complex, so we have to be there to support each other, both on an operational and strategical level.

What is the next step for RegSmart?

Since the start, there has been a high demand for our services. We will continue to grow with more colleagues and expand our business. We aim to be the number one preferred regulatory partner in development projects.