Regulatory Support Manager Cell&Gene Therapy

Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
We are looking for a Regulatory Support Manager Cell & Gene Therapy 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 Biotechnology, Life Sciences or other related field
Five or more 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.
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 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