Per Asimus

Experience

• 

  AstraZeneca

  May 2000 - Jan 2010

  Working with late stage projects with scal-up and technology transfer to commercial manufacturing sites. I was project responsible/delivery team leader within formulation science for IR/ OCR projects both NCE projects and line extensions. IR & Modified release formulation development, functional lead. IR formulation development, tech transfer, NDA/MAA applications

  • Senior Scientist Technology Transfer

    Jan 2007 - Jan 2010

  • Senior Scientist Product Development

    Mar 2006 - Jan 2007

  • Scientist Product Development

    May 2000 - Mar 2006
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  AstraZeneca

  Nov 2010 - Aug 2019

  Regulatory Affairs Director and Global Regulatory Lead/ EU Regulatory Lead within respiratory therapeutic area. I am accountable for the development and implementation of the regulatory strategies for different products in different phases of development and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. I am also responsible for products on the market and its license to operate and LCM activities.I am also leading and developing a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirements, leading the planning and construction of the global dossier and core prescribing information and leading the development and implementation of innovative strategies to maximize the likelihood of regulatory success.My achievements in this role has been so far:• Approval of a major type II variations in EU (new indication and device switch) • Leading the regulatory work during development of new indications for an existing product on the market• I have been part of EMA and Health Canada scientific advice in my role as EU or global regulatory lead. Show less

  • Director Regulatory Affairs

    Oct 2016 - Aug 2019

  • Associate Director - Global Regulatory Affairs

    Sept 2015 - Oct 2016

  • Associate Director Regulatory CMC

    Jun 2011 - Sept 2015

  • Senior Scientist Formulation Science

    Nov 2010 - May 2011
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  AstraZeneca

  Oct 2019 - now

  Working with Respiratory products with study design, clinical program oversight, submission and GCP inspections Working with respiratory drug projects in registration phase and respiratory products on the market. Leader of a large regulatory execution team. Lead regulatory project manager for several respiratory brands. Leader of a relative large global regulatory execution team that is managing several major respiratory products on the market as well as in registration phase and launch phase.

  • Senior Section Director, Clinical Operations

    Nov 2024 - now

  • Global Clinical Operations Program Director

    Jul 2022 - Nov 2024

  • Regulatory Affairs Project Director

    Aug 2021 - Jul 2022

  • Regulatory Project Director at AstraZeneca

    Apr 2021 - Aug 2021

  • Associate Regulatory Project Director

    Oct 2019 - Apr 2021