Regulatory Affairs - Local Presence and Expertise

Kristine Nygren, Director Regulatory, Sweden

Kristine holds a BSc in Pharmacy and is a licensed Pharmacist, with postgraduate studies in Applied Physiology, Clinical Anatomy and Pharmacology. With more than 25 years of experience in Regulatory Affairs across the pharmaceutical and medical device industries, she brings extensive expertise to the field. Her professional background also includes over 15 years of leadership experience gained through various management roles within the pharmaceutical industry and at the Swedish Medical Products Agency. Kristine is based at LINK Medical’s office in Uppsala, Sweden.

Morten Becker Gaardlykke, Director Regulatory, Denmark

Morten holds an MSc in Pharmacy. With more than 20 years of Regulatory experience from Global Pharma he has accumulated much knowledge about the Regulatory environment in Denmark and post-marketing lifecycle management. Product launches are also one of his specialties. He is a trusted partner, who will help customers to navigate the complex regulations with confidence and clarity. He is based at LINK Medical’s office in Copenhagen, Denmark.

Birgit Jensen, Group Manager Regulatory, Norway.

Birgit holds a BSc in Pharmacy. With 25 years of experience in the Pharmaceutical and MedTech industries, she has developed broad expertise across many aspects of Regulatory Affairs and Marketing Compliance. A strong focus on Nordic collaboration, combined with a service-minded and solution-oriented approach, characterizes her way of working. Birgit is based at LINK Medical’s office in Oslo, Norway

When relevant, a dedicated Project Manager will ensure collaboration and alignment across the Nordics, e.g. for labelling documents and common Nordic packs.