Experience

Rhythm Pharmaceuticals Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Head of International Regulatory Affairs at Rhythm Pharmaceuticals

  • Sep 2022 - Present



CSL Vifor

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head of Regulatory Affairs Avacopan Development Programs

  • Sep 2018 - Jun 2022

  Lead Vifor's rare disease drug avacopan (TAVNEOS) development registration programs through phase 2/3 to submission and successful approval in the European Union and in Japan, with further registrations on track in other major regulatory jurisdications.

• Head of Regulatory Affairs Development Therapeutics

  • Jan 2017 - Aug 2018

  Led the Regulatory Affairs Development Therapeutics Teams and provided regulatory strategy and guidance on tactics for new drug development projects and life cycle management of established products with emphasis on pursuing registration activities in key strategic markets in EU, Switzerland, USA, Canada and Australia.



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Head Regulatory Affairs Biosimilars

  • Sep 2015 - Dec 2016

  Led the regulatory affairs activities within the Biosimilars Business Unit at Biogen International GmbH. Established and drove a regulatory affairs network with external partners to maximally enable fast launch of the biosimilar franchise of Biogen in the top markets within the European Union. Led the regulatory affairs activities within the Biosimilars Business Unit at Biogen International GmbH. Established and drove a regulatory affairs network with external partners to maximally enable fast launch of the biosimilar franchise of Biogen in the top markets within the European Union.



Independent Advice for Business

• United Kingdom
• Business Consulting and Services
• 1 - 100 Employee

• Senior Advisor

  • Nov 2012 - Aug 2015

  Provided advice, built strategy and delivered execution tactics to startup and established pharmaceutical and biotech companies in drug development, regulatory affairs and organizational development. Provided advice, built strategy and delivered execution tactics to startup and established pharmaceutical and biotech companies in drug development, regulatory affairs and organizational development.



BioPartners

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• CEO

  • May 2009 - Oct 2012

  Led Biopartners GmbH, Switzerland with its main focus on development and registration of biosimilar and biobetter products.

• Chief Scientific Officer

  • May 2007 - Apr 2009

  Defined strategy and supervised development plans. Led the evaluation, selection and decision-making for selecting service partners, performing the development work (CROs, CMOs, experts). Directly led one of the key development project teams and provided scientific and strategic direction to further projects in the portfolio.

• Head of Pharma Development

  • Nov 2001 - Apr 2007

  Led the overall development of biotechnology derived molecules up to marketing authorization. Successfully pioneered the biosimilar approval pathway with CHMP/EMA for registration of a recombinant human growth hormone and led the development and registration from phase I through to phase III for a long-acting recombinant human growth hormone (biobetter).



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Global Regulatory Affairs Team Leader

  • Apr 1998 - Oct 2001

• Senior Regulatory Affairs Manager

  • Jan 1995 - Mar 1998

• Senior Regulatory Affairs Manager

  • Aug 1991 - Dec 1994