Experience

IWA Consulting

• Denmark
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Regulatory Science Specialist

  • Mar 2021 - Present



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Specialist, CMC Small Molecules

  • May 2016 - Mar 2021

  Working within life cycle management and post-approval activities with focus on CMC and acting as regulatory CMC responsible providing operational and strategic global regulatory CMC support and advice.Post-approval activities through Cross Functional Product and Project Teams and RA-focus team: Change Control assessment, planning and strategies, coordinating regulatory authoring and review process during variation dossier compilation, ensuring timeliness for the deliverables, provide in-put to the Annual Product Quality review, leading Regulatory CMC related Health Authority interactions, liaising within GPS on upcoming demands for Reg Affairs, driving Regulatory CMC excellence. Show less

• Regulatory Affairs Professional

  • Sep 2013 - Apr 2016

• Regulatory Affairs Coordinator

  • Dec 2006 - Aug 2013



Billev Pharma ApS

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Dec 2002 - Nov 2006



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Assistant

  • 1996 - Nov 2002



Trianglen Pharmacy, Østerbro

• Copenhagen, Capital Region, Denmark

• Pharmaconomist

  • 1993 - 1996