Regulatory Support Manager

Cytiva Sweden AB / Administratörsjobb / Uppsala
2020-06-18
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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).

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
2020-06-18

Så ansöker du
Sista dag att ansöka är 2020-07-18
Klicka på denna länk för att göra din ansökan

Adress
Cytiva 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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