Experience

SDS Life Science - a Cytel company

• Sweden
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director Regulatory Affairs

  • May 2021 - Present



Sobi - Swedish Orphan Biovitrum AB (publ)

• Sweden
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Global Regulatory Affairs Haematology

  • Dec 2019 - May 2021

  Director Global Regulatory Affairs for Sobi Haematology products with a team responsible for new MAA's and post marketing activities in EU, Switzerland, Middle East, North Africa, Russia, Japan, Canada and China (small molecules and biologics), as well as regulatory activities for development and submission of new indications.

• Global Regulatory Affairs Manager

  • Oct 2017 - Dec 2019

  Global Regulatory Affairs Manager within CMC for biological products post marketing in EU (centralized procedure) and Switzerland. New MAA's and post marketing in Middle East, North Africa and Russia.



BioArctic

• Biotechnology Research
• 1 - 100 Employee

• Program Manager

  • Jan 2015 - Sep 2017

  Program manager for Phase I/II project targeting complete spinal cord injury performed in collaboration with the Karolinska Hospital. Combined medicinal and medtech product (recombinant growth factor and biodegradable device) with patient recruitment in Scandinavian and Baltic countries.

• CMC Specialist / Manager External Manufacturing

  • Jan 2012 - Sep 2017

  Management of CDMOs and CROs world wide for manufacture of biological products for Phase I/II clinical studies.

• Specialist Cell Culture

  • Aug 2008 - Dec 2011

  In-house manufacture of antibodies for preclinical studies.



Biovitrum

• Stockholm, Sweden

• Cell Culture Specialist

  • Sep 2006 - Aug 2008

  Process development for large scale manufacture of biopharmaceuticals. Process development for large scale manufacture of biopharmaceuticals.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Diploma thesis

  • Aug 2000 - Jan 2001

  Dept. of Lead Discovery, Södertälje Dept. of Lead Discovery, Södertälje