Regulatory Affairs Manager
GE Healthcare Bio-Sciences AB / Marknadsföringsjobb / Stockholm
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hela Sverige GE Healthcare Life Sciences provides products and services used as tools for biopharmaceutical manufacturing, drug discovery and the latest in cellular technologies, thereby enabling our customers around the world to be more productive, effective and creative. Our motivation is to create better health for more people. Through our five decades of supporting the biopharmaceutical industry and its research partners to become more productive, we are helping to reduce costs, increase access and improve quality in the healthcare system. We use our expertise and know-how in imaginative ways to work with our customers to provide what's needed today and create products and solutions to enable the medical treatments of tomorrow.
We add value to our customers by:
• Providing cutting-edge research tools that give deeper insights into cell function to enable disease diagnosis and the development of treatments.
• Enabling manufacturing productivity: we provide solutions for the entire bioprocess workflow (i.e. start-to-finish bioprocessing) helping our customers to develop and manufacture biopharmaceuticals more efficiently.
• Providing high quality support and maintenance services.
Role Summary/Purpose:
In this role you will be responsible for the RA processes for our pharmaceutical in-vivo diagnostic business in Sweden. This includes responsibility for all regulatory activities that supports the compliance, registration and promotion of our products in the country, as well as acting as national Pharmacovigilance and Responsible Person for the pharmaceutical/wholesaler licenses. You will collaborate with the regional RA Manager, the central RA functions, commercial and marketing groups.
Essential Responsibilities:
• Main regulatory point of contact with national regulatory authorities on behalf of GE Healthcare.
• Responsible person for the national pharmaceutical/wholesaler licenses (GMP and GDP).
• Local Pharmacovigilance person supporting central PV.
• Responsible for ensuring local regulatory compliance for GE Healthcare products.
• Responsible person for promotional material in local market and coordinator for the regional review of promotional material.
• Responsible for providing regulatory support to commercial business priorities.
• Responsible for preparing, maintaining and reviewing local Quality Management System including training and internal audit locally in accordance with GxP and local SOPs.
• Comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position.
• Complete Quality & Compliance training within the defined deadlines.
• Proactive in assessing impact of new regulations in local market
• Provide national regulatory support as requested in relation to authority inspections.
• Provide national regulatory input and approval related to Change Control processes for artwork.
Qualifications/Requirements:
• Bachelor's Degree and minimum 5 years of regulatory affairs experience from the medical device or pharmaceutical industry or with medical product regulatory agencies, with experience in dealing directly with regulatory authorities.
• Ability to prioritize, plan and evaluate deliverables.
• Ability to work with minimal daily supervision on projects and activities.
• Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner.
• Fluent in Swedish.
• Experience in using spreadsheet and presentation software.
• EU work permit.
Desired Characteristics:
• Ability to interact, lead and work with multiple functions/stakeholders.
• Team and business oriented - collaborate with others to solve business problems.
• Clear thinker and flexible.
• Strong PC-skills.
Publiceringsdatum2015-01-14Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2015-02-04
Ansök via företagets webbplats
Klicka på denna länk för att göra din ansökanJobbnummer: 1980025
FöretagGE Healthcare Bio-Sciences AB
AdressGE Healthcare Bio-Sciences AB
Björkgatan 30
75184 UPPSALA
Övriga kontaktuppgifterTelefonnummer: 018-6120000
Jobbnummer 2128478
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