- Notera att ansökningsdagen för den här annonsen kan ha passerat. Läs annonsen noggrant innan du går vidare med din ansökan.
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 ([email protected]).
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.