Experience

Ozack ApS

• Denmark
• Business Consulting and Services
• 1 - 100 Employee

• CEO

  • Jan 2018 - Present

  Increase progress in development of needed medicinal products through providing knowledge on how to navigate the regulatory maze and agency interactions through development of medicine within all phases of drug development. Increase progress in development of needed medicinal products through providing knowledge on how to navigate the regulatory maze and agency interactions through development of medicine within all phases of drug development.



AFYX Therapeutics

• Denmark
• Biotechnology
• 1 - 100 Employee

• VP Regulatory Affairs

  • Feb 2018 - Present



RhoVac

• Biotechnology
• 1 - 100 Employee

• Senior Director, Regulatory Affairs

  • Oct 2016 - Present

  • Develop Regulatory Strategies • Plan, coordinate, and deliver regulatory activities • Advice on cross functional development progress • Develop Regulatory Strategies • Plan, coordinate, and deliver regulatory activities • Advice on cross functional development progress



Københavns Universitet - University of Copenhagen

• Denmark
• Research
• 700 & Above Employee

• External Associate Professor

  • Mar 2017 - Present

  • Leading the mandatory module "Clinical Development - Efficacy of Medicines" • Part of the Master of Medicines Regulatory Affairs. http://mra.ku.dk/about/ • Contribute to life-long-learning for professionals in Regulatory Affairs • Leading the mandatory module "Clinical Development - Efficacy of Medicines" • Part of the Master of Medicines Regulatory Affairs. http://mra.ku.dk/about/ • Contribute to life-long-learning for professionals in Regulatory Affairs



Biotrack ApS

• Copenhagen Area, Denmark

• Managing Director & Regulatory Affairs Executive

  • Aug 2016 - Dec 2017

  Biotrack (http://biotrack.dk) provide tailored plug-in management and execution power fitted for biotech with the approach: Navigate - Execute - Communicate • specialized in the areas of regulatory affairs, medical writing, and project management • work with our customer to create a viable, agile plan through the regulatory maze • ensure knowledge and documentation is managed and retained in-house Biotrack (http://biotrack.dk) provide tailored plug-in management and execution power fitted for biotech with the approach: Navigate - Execute - Communicate • specialized in the areas of regulatory affairs, medical writing, and project management • work with our customer to create a viable, agile plan through the regulatory maze • ensure knowledge and documentation is managed and retained in-house



Shionogi Inc. (U.S.)

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Vice President Regulatory Affairs

  • Sep 2015 - Jun 2016

  • Interim management • European Regulatory Team Head • Build Regulatory organisation to be fit for purpose • Structure process and operations to increased efficiency • Interim management • European Regulatory Team Head • Build Regulatory organisation to be fit for purpose • Structure process and operations to increased efficiency



UCB

• Belgium
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Vice President Regulatory Affairs Europe and Early Projects

  • May 2013 - Jun 2015

  • Global Regulatory Affairs Lead for Europe and all early development projects• Cross country leadership of employees based in Belgium, Germany, and UK• Organizational transformation from 80 to 40 FTEs

• Sr Director and Vice President Regulatory Affairs EU & Intl.

  • Jun 2012 - Apr 2013

  • Global target markets outside US and Canada, including Brazil, Russia, India, and China (BRIC)• 55 employees and 25 insourced contractors



Genmab

• Denmark
• Biotechnology Research
• 700 & Above Employee

• Vice President Regulatory Affairs

  • Jan 2010 - May 2012

  • Target to market global regulatory strategies development for all Genmab products• Communication strategies with regulatory agencies • Risk management evaluation• 3-7 employees leading global regulatory affairs• Member of Global Executive Management Team of Genmab

• Senior Director Regulatory Affairs

  • Jul 2008 - Dec 2009

  • 20 employees leadership of Regulatory Affairs & Operations Department• Global regulatory strategies with US and EU focus• Joint Development Team with our partner GSK

• Director Regulatory Affairs

  • Nov 2007 - Jun 2008

  • Led department of 20 FTEs being Global Regulatory Affairs & Operations• Regulatory co-development with external partner (GSK) and the Genmab submission management team for Arzerra Regulatory dossier (BLA/MAA)• Red regulatory thread through all phases of development

• Global Regulatory Project Leader

  • Nov 2006 - Oct 2007

  • Global Submission Management Team leadership for Arzerra at Genmab • Global orphan regulatory strategy for advanced oncology product in Clinical Phase 3.



Action Pharma

• Holte, Denmark

• Vice President Project Management & Regulatory Affairs

  • Nov 2005 - Dec 2006

  • 6 small virtual biotech companies in Incuba Venture Portfolio • Regulatory strategic advice and Global Project management • Agency communication strategy linked to key investor decision points • Development & manufacturing plans of the drug substances and drug products • Non-clinical (pharmacology & toxicology) and clinical plans across numerous CROs/CMOs. • 6 small virtual biotech companies in Incuba Venture Portfolio • Regulatory strategic advice and Global Project management • Agency communication strategy linked to key investor decision points • Development & manufacturing plans of the drug substances and drug products • Non-clinical (pharmacology & toxicology) and clinical plans across numerous CROs/CMOs.



Actavis (now Allergan)

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director International Registration

  • Jan 2005 - Oct 2005

  • Actavis Sales & Marketing International leadership of Regulatory Affairs • Pharmacovigilance function to ensure European compliance • International regulatory team leadership of 30 FTEs • Markets included the Scandinavian area, Baltic’s, CEE, Turkey, Serbia, Russia, Ukraine and C.I.S • Actavis Sales & Marketing International leadership of Regulatory Affairs • Pharmacovigilance function to ensure European compliance • International regulatory team leadership of 30 FTEs • Markets included the Scandinavian area, Baltic’s, CEE, Turkey, Serbia, Russia, Ukraine and C.I.S



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head of Department, Regulatory Affairs Initial Filing

  • 2000 - 2004

  • Achievement of the Marketing Authorization in EU, US and Japan for entire LEO Pharma portfolio • Global Regulatory Affairs Lead for quality, non-clinical and clinical development paths • Dermatology (psoriasis, dermatitis, acne), biological lung surfactant, oncology, rheumatoid arthritis • Achievement of the Marketing Authorization in EU, US and Japan for entire LEO Pharma portfolio • Global Regulatory Affairs Lead for quality, non-clinical and clinical development paths • Dermatology (psoriasis, dermatitis, acne), biological lung surfactant, oncology, rheumatoid arthritis



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Group Manager, Regulatory Affairs

  • 1995 - 1999

  • EU, US, JP and 24 other major countries • All development stages and life cycle management for vitamin D analogues • Dermatology, biological lung surfactant, oncology, and rheumatoid arthritis • Regulatory Intelligence in US, EU, and JP • EU, US, JP and 24 other major countries • All development stages and life cycle management for vitamin D analogues • Dermatology, biological lung surfactant, oncology, and rheumatoid arthritis • Regulatory Intelligence in US, EU, and JP



Dumex

• Food and Beverage Services
• 100 - 200 Employee

• Regulatory Officer

  • 1993 - 1995

  Generics regulatory dossiers for EU and project manager for a development project. Generics regulatory dossiers for EU and project manager for a development project.



Norwegian Medicines Agency

• Norway
• Government Administration
• 1 - 100 Employee

• Medical Assessor

  • 1992 - 1993

  Generic dossiers evaluated clinically for applicability to Norwegian legislation Generic dossiers evaluated clinically for applicability to Norwegian legislation