Regulatory Support Manager
Cytiva Sweden AB / Administratörsjobb / Uppsala
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Solna,
Umeå eller i
hela Sverige Help us improve access to life-changing therapies that can transform human health
Do you have a passion for understanding customer situations and needs, and supporting customers? Then we would love to hear from you!
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 17 employees across the world.
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 Biopharmaceuticals, Biotechnology, Life Sciences or related field
Several years of experience in quality, product management, R&D/development or other related field for understanding of GMP and regulatory requirements in the bioprocess industry. Experience from the cell and gene therapy area is highly valued.
Strong written and verbal communication skills in both English and Swedish
Organized, accurate, target oriented, quality minded and customer oriented
Flexible and service minded with the ability to collaborate
Strong drive and ability to work independently. Interest in developing new support offerings for the business needs.
For questions about the role 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.
Our business is growing quickly and we hire across the board. Interview and selection will happen continuously and an opening can be filled before last day of application, February 28th.
Want to know more? Take a look at our Careers website, Instagram och LinkedIn page!
Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher's unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life's Potential.
Publiceringsdatum2021-02-05Så ansöker duSista dag att ansöka är 2021-03-05
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 5560711
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