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Senior Regulatory Support Manager
3 months ago
Be part of something altogether life-changing
Working at Cytiva 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.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
We're looking for a Senior Regulatory Support Manager to join Cytiva's Customer Regulatory Support (CRS) team at our facilities in Uppsala. As Senior Regulatory Support Manager, you are responsible for providing support to Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers' requests for quality, regulatory and technical-related information. As a member of the Customer Regulatory Support team, you will add value to BioProcess products and demonstrate a commitment to customer satisfaction.
What you'll do:
- Lead area team within CRS or over-arching product/area activities and critical projects.
- Build and maintain knowledge and understanding of customers' regulatory requirements related to the BioProcess business at a high level, specifically regarding product area chromatography resin.
- Ensure availability of right Regulatory Support documentation for customers in regulated environment.
- Participate/drive in creating and updating guidelines and steering documents.
- Act as regulatory support expert in projects and discussion partner to R&D, QA, Product Management and other functions and regions.
- Respond efficiently and promptly to customers' regulatory based issues, which will include necessary investigations, preparations and delivery of certificates, use of available internal and external databases and other relevant databases.
- File and maintain complete documentation of questions and answers in databases; specify, prepare, update and review regulatory support documentation, including RSF, VG, VSF, CCN, statements, certificates and other regulatory related documentation for new and existing products.
The essential requirements of the job include:
- Bachelor of Science in Chemistry, Biotechnology, Pharmacy or equivalent educational background.
- At least 8 years' of experience from relevant positions within Quality Assurance, Regulatory, or Product Management.
- Excellent communication skills and fluency in English, both written and spoken.
- Deep understanding of GMP and knowledge of regulatory requirements in Pharmaceutical, Biotechnology, Medical Device, or Life Science industry.
It would be a plus if you also have:
- Experience leading cross-functional activities in large matrix organizations.
- Fluency in the language of the country of employment.
- Experience in customer communication.
Interview and selection will happen continuously and the opening can be filled before last day of application. For questions regarding the role please contact hiring manager Henrik Norberg We look forward to hearing from you
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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
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