Karin Fredriksson

Karin Fredriksson Email and Phone Number

Director Labelling Strategy at AstraZeneca AB, Sweden @ AstraZeneca
cambridge, cambridgeshire, united kingdom
Karin Fredriksson's Location
Greater Gothenburg Metropolitan Area, Sweden
Karin Fredriksson's Contact Details

Karin Fredriksson personal email

n/a
About Karin Fredriksson

Karin Fredriksson is a Director Labelling Strategy at AstraZeneca AB, Sweden at AstraZeneca. She possess expertise in regulatory affairs, regulatory requirements, pharmaceutical industry, clinical research, clinical trials and 29 more skills.

Karin Fredriksson's Current Company Details
AstraZeneca

Astrazeneca

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Director Labelling Strategy at AstraZeneca AB, Sweden
cambridge, cambridgeshire, united kingdom
Website:
astrazeneca.com
Employees:
59317
Karin Fredriksson Work Experience Details
  • Astrazeneca
    Director Labelling Strategy
    Astrazeneca Nov 2023 - Present
    Göteborg, Västra Götaland, Sverige
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  • Astrazeneca Gothenburg
    Global Labeling Strategy Associate Director
    Astrazeneca Gothenburg Jun 2021 - Oct 2023
    Providing strategic labelling expertise, typically for drug-device combination products, to global regulatory submission and execution teams. Leading product labelling cross-functional teams, for development and implementation of core product information in US and EU market product information• Partnering with Human Factor experts leading development of instruction for use for device platforms. Providing project teams with regulatory labelling negotiations and response strategies.
  • Wellspect Healthcare
    Senior Manager Regulatory Affairs
    Wellspect Healthcare Mar 2019 - May 2021
    Mölndal, Västra Götalands Län, Sverige
    Strategic support to medical device development and device change teams, (class I, Is, IIa, IIb) for legal compliance and claims substantiation. PMS/Vigilance incident reporting and responsens to authorities. EU Medical Device Regulation subject matter expert and strategic lead in MDR transition project. Interpretation of external guidance. Supporting notified body applications. Extensive review of labeling, clinical evaluations, risk management and other product technical documentation for regulatory compliance. Internal auditor of organisation compliance to QMS, MDD/MDR, ISO 13485:2016, QSR. External audit experience.
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  • Wellspect Healthcare
    Regulatory Affairs Manager
    Wellspect Healthcare Oct 2015 - Mar 2019
    Gothenburg, Sweden
    Global resource providing regulatory support to medical device development and device change teams, (class I, Is, IIa, IIb) to ensure legal compliance and claims are met. EU MDR subject matter expert. Supporting global markets with regulatory advice and documentation for registration and licence maintenance. Performing vigilance and incident reporting. Participating in external networks. Working closely with Quality Assurance, R&D, Medical Affairs, Marketing and brand managers. Internal auditor of organisation compliance to QMS, MDD, ISO 13485:2016, QSR.
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  • Astrazeneca R&D
    Regulatory Affairs Director
    Astrazeneca R&D Sep 2014 - Sep 2015
    Sweden
    Lead for European regulatory strategies and planning of activities in Phase 2a-b projects in respiratorn and inflammatory diseases. Providing regulatory advice and support to clinical study protocols, DSURs, paediatric investigation plans etc.
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  • Sca Hygiene Products
    Global Regulatory Affairs Lead, Medical Device
    Sca Hygiene Products Jun 2013 - Sep 2014
    Gothenburg, Sweden
    Global resource for ensuring legal compliance for medical devices, supporting regions and countries with advice and documentation for registration of company assortment. Authoring internal SOPs for medical device and risk management and providing training to the organization. Representing company in industry association.
  • Astrazeneca R&D, Sweden
    European Regulatory Affairs Director
    Astrazeneca R&D, Sweden Jan 2011 - Jun 2013
    Sweden
    Leading life cycle management activities; PSUR worksharing and paediatric worksharing submissions, PRMP-updates and input to MC local plans, coordinating submissions of type IA-II variations, PIP applications and compliance check etc.
  • Astrazeneca R&D
    Associate Director Regulatory Affairs/Regulatory Affairs Manager
    Astrazeneca R&D Nov 2005 - Dec 2010
    Astrazeneca R&D, Sweden
    Co-ordinating European licens renewal and variations applications, response submissions, paediatric investigational plan submissions and subsequent modification requests. Managing product information changes. Providing local marketing company support.
  • Astrazeneca R&D, Sweden
    Clinical Outsourcing Manager (Com)/Senior Com
    Astrazeneca R&D, Sweden Jan 2000 - Oct 2005
    Co-ordinating Request for Proposals and leading selection process and contract negotiation for outsourcing of various clinical study services. Supporting clinical study teams in issue resolution and contract change requests. Project managed the development of a global contracts database.
  • Astrazeneca R&D, Sweden
    Associate Director/Clinical Project Leader/Clinical Research Manager
    Astrazeneca R&D, Sweden Jan 1991 - Dec 1999
    Developing clinical project plans and study outlines, managing clinical study budgets and representing clinical on cross-functional teamsManaging and reporting multi-centre clinical studies in different phases of development, including e.g. authoring study protocols and -reports, co-ordinating MC monitors and external vendors, arranging investigators meetings, and facilitating abstracts/posters presentation

Karin Fredriksson Skills

Regulatory Affairs Regulatory Requirements Pharmaceutical Industry Clinical Research Clinical Trials Regulatory Submissions Cross Functional Team Leadership Clinical Development Medical Devices Gcp Drug Development Project Management Pharmacovigilance Ectd Gxp Fda Sop Customer Relations Clinical Outsourcing Iso 13485 Iso 14971 Risk Management Cardiovascular Disease Paediatric Investigational Plan Psurs Urology Quality System Klinisk Utveckling Biovetenskap Medicinsk Utrustning Cro Internrevisor Technical File Medical Device Directive

Karin Fredriksson Education Details

  • Uppsala University
    Uppsala University
    Pharmacist

Frequently Asked Questions about Karin Fredriksson

What company does Karin Fredriksson work for?

Karin Fredriksson works for Astrazeneca

What is Karin Fredriksson's role at the current company?

Karin Fredriksson's current role is Director Labelling Strategy at AstraZeneca AB, Sweden.

What is Karin Fredriksson's email address?

Karin Fredriksson's email address is ka****@****sca.com

What schools did Karin Fredriksson attend?

Karin Fredriksson attended Uppsala University.

What skills is Karin Fredriksson known for?

Karin Fredriksson has skills like Regulatory Affairs, Regulatory Requirements, Pharmaceutical Industry, Clinical Research, Clinical Trials, Regulatory Submissions, Cross Functional Team Leadership, Clinical Development, Medical Devices, Gcp, Drug Development, Project Management.

Who are Karin Fredriksson's colleagues?

Karin Fredriksson's colleagues are He Kl, Ciro Meo, Joanna Ćwikła, Fee Parkes, Mirko Terrenzio, Lucian Cook, Ahmed Badawy.

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