Senior Consultant

Malin Waage

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  
Before NDA

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.

 

 

Malin Waage

LinkedIn

 

Stay up to date

Contact us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World