Regulatory Support Manager
Cytiva Sweden AB / Administratörsjobb / Uppsala
2020-06-18
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➡️ Klicka här för den senare publicerade platsannonsen "Regulatory Support Manager" (publicerad 2021-02-05) ⬅️
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Solna,
Umeå eller i
hela Sverige Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a Regulatory Support Manager to work with our expert Customer Regulatory Support team of 15 employees across the world. Do you have a passion for understanding customer situations and needs, and supporting customers? Then we would love to hear from you.
What you'll do
• Participate in projects to develop regulatory support documentation for products in customers regulated environments, and update after launch
• Perform necessary investigations, and prepare and deliver statements and certificates
• Respond efficiently and promptly to customers regulatory/quality based issues
• Participate in change control cases, be the customer advocate, prepare and publish the change notification letter or package
• Participate in creating and updating processes, guidelines and steering documents
Who you are
• Bachelor of Science degree in Chemistry, Pharmacy or other related field
• Five or more years of experience in quality, product management or other related field for understanding of GMP and regulatory requirements in the bioprocess industry
• Excellent English and Swedish level
• Organized, accurate, target oriented, quality minded and customer oriented
• Strong written and verbal communication skills
• Flexible and service minded with the ability to collaborate
• Strong ability to work independently, drive
For questions related to this opening, please contact hiring manager Ondina Åsberg (
ondina.asberg@cytiva.com).
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you'll feel right at home here. If you're flexible, curious and relentless, you'll belong. If you are excited about a global culture, this can be the place to further your career.
Publiceringsdatum2020-06-18Så ansöker duSista dag att ansöka är 2020-07-18
Klicka på denna länk för att göra din ansökanAdressCytiva Sweden AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cytiva Sweden AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Arbetsplats GE Healthcare Bio-Sciences AB
Jobbnummer 5270376
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