Malin has been with NDA since 2019, with more than 20 years of experience in regulatory affairs, leading regulatory strategy development as well as regulatory submissions.
Key Areas Of Expertise
- Defining product classification (regulatory framework) for development products (drug/device/food)
- Developing regulatory strategies for drug development and drug repurposing projects
- Providing guidance in regulatory issues and interpretation of related guidelines
- Scientific Advice/Protocol Assistance procedures with national European authorities, EMA and the FDA
- Cross-functional project management of regulatory submissions including clinical trial applications and INDs
- Leading global regulatory development teams
- Project management of regulatory deliverables, PIP, iPSP and renewal of ODD
- Experience from multiple therapeutic areas including Pain and inflammation, Women's health, Dermatology, Antidotes, HIV, Gastroinestinal, Anaesthesia and Local Anaesthetics
Malin worked for a Nordic consultancy focusing on drug development where she had a dual role of working as a senior regulatory consultant and leading the development of the internal infrastructure and processes.
She also worked with products in both the pre- and post-approval phases, in marketing companies as well as globally in R&D. During this period she primarily worked with drugs for Pain management and Women’s health.