Regulatory Support Manager

GE Healthcare Bio-Sciences AB / Administratörsjobb / Uppsala
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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). Please apply no later than June 14. Interviews will happen continuously.

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.

Publiceringsdatum
2020-05-29

Så ansöker du
Sista dag att ansöka är 2020-06-14
Klicka på denna länk för att göra din ansökan

Adress
GE Healthcare Bio-Sciences AB
Björkgatan 30
75184 Uppsala

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
GE Healthcare Bio-Sciences AB (org.nr 556108-1919)
Björkgatan 30 (visa karta)
751 84  UPPSALA

Jobbnummer
5244549

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