Sofia Kyhlstedt
VP Scientific Affairs at Karo Pharma- Claim this Profile
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Experience
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Karo Pharma
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Sweden
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Pharmaceutical Manufacturing
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1 - 100 Employee
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VP Scientific Affairs
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Oct 2019 - Present
Managing the global and and affiliate teams of scientific affairs in Karo of approx 43 employees as well as responsible for the infrastructure of the global and local service providers for Karos global commercialization of consumer healthcare goods within OTC, Medical Device. Foods and cosmetics and Rx. Scientific Affairs consists of Medical Affairs & Clinical Operations, Regulatory, Quality Assurance and Patient safety. Member of the corporate management team with clear dedication to the development of the company and its individuals ensuring the provision of a safe work place and employer as well as delivering the Karo vision by execution within the field of science. Show less
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Trimb Healthcare
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Sweden
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Medical Equipment Manufacturing
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1 - 100 Employee
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Head of Scientific Affairs
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Apr 2019 - Sep 2019
Managing the team of Regulatory Affairs, Quality Assurance, Product development and Medical Affairs for Trimb group product portfolio including pharmaceutical, medical devices, food supplement and cosmetic products. Project compliance control for MDR, TechTranfers, Product development and launches for the Trimb group portfolio to secure Trimbs growth and development in compliance with regulations and standards.Managing requirement specifications of products as well as suppliers in compliance with GDP/GMP and ISO13485 Show less
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Director Regulatory and Quality Affairs
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Jul 2017 - Jun 2019
Managing the team of RAQA for the Trimb portfolio of pharmaceuticals, medical devices, cosmetics and foods and their applicable regulations.Regulatory management of the pharmaceutical portfolio where we are MAH including CMC and CMO projects and regulatory management of the medical device portfolio where we are Legal Manufacturer. Quality management according to GDP and applicable GMP and ISO 13485.Cross functional projects to secure Trimbs growth and development in compliance with regulations and standards. Show less
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Head of Regulatory Affairs Pharma
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Jan 2017 - Jun 2017
Establishing the Regulatory Affairs Department managing the pharmaceutical portfolio of MAH Trimb Healthcare
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Bausch + Lomb
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Manager Regulatory Affairs, Responsible Person GDP
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Aug 2015 - Jan 2017
Lead Regulatory Affairs Nordic B&L portfolio in pharmaceuticals, medical devices & cosmetics Quality management for pharmaceutical, medical device, cosmetics portfolio managing QMS, working procedures&processes, project management. Responsible person for GDP Medical information responsible Nordics Project and process management; Launch management, Transfer management and Supply/demand. Marketing material compliance. Lead Regulatory Affairs Nordic B&L portfolio in pharmaceuticals, medical devices & cosmetics Quality management for pharmaceutical, medical device, cosmetics portfolio managing QMS, working procedures&processes, project management. Responsible person for GDP Medical information responsible Nordics Project and process management; Launch management, Transfer management and Supply/demand. Marketing material compliance.
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Actavis
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United States
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Pharmaceutical Manufacturing
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Nordic Regulatory Affairs Specialist
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Sep 2012 - Aug 2015
Regulatory Affairs Nordics Project management - Art-work process project management - Regulatory/supply process project management Regulatory Affairs Nordics Project management - Art-work process project management - Regulatory/supply process project management
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Orion Pharma
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Officer
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Jun 2011 - Aug 2012
Regulatory Pharmacovigilance Quality Regulatory Pharmacovigilance Quality
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Apotek Hjärtat
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Sweden
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist/Apotekare
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Jan 2010 - May 2011
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Apoteket AB
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Sweden
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacist/Apotekare
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Aug 2009 - Dec 2009
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Education
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Copenhagen Business School
Open innovation in Life Science 5 ECTS -
Copenhagen Business School
Business Development In Life Science 5 ECTS -
M-gruppen
Project Managment -
Göteborgs universitet / University of Gothenburg
MSc in Pharmacy