Regulatory Support Manager

1 week ago

Uppsala, Sweden Danaher Corporation Full time

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 Regulatory Support Manager to join Cytiva’s Customer Regulatory Support (CRS) team at our site in Uppsala. As Regulatory Support Manager, focusing on our chromatography resin product portfolio, 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:

  • Build and maintain knowledge and understanding of customers’ regulatory requirements related to the bioprocess business at a high level.

  • Develop and update regulatory support documentation for products in customers’ regulated environments.

  • Perform necessary investigations and prepare and deliver statements and certificates.

  • Participate in creating and updating guidelines and steering documents.

  • Act as regulatory support expert and discussion partner to R&D, QA, Product Management and other functions and regions.

  • Participate in project teams as regulatory support expert.

  • 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 degree in Chemistry, Pharmacy or related field.

  • A few years of experience from relevant positions within Quality Assurance, Regulatory, or Product Management.

  • Good understanding of GMP and knowledge of regulatory requirements in the bioprocess industry.

  • Excellent communication skills and fluency in English, both written and spoken.

It would be a plus if you also have:

  • Experience of working in large matrix organizations.

  • Fluency in the language of the country of employment.

  • Experience in customer communication.

We are seeking a candidate who is organized, accurate, and target-oriented, with a strong focus on quality and customer service. The ideal candidate should be flexible, service-minded, and able to collaborate effectively across teams.

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, Senior Manager Customer Regulatory Support, henrik.norberg@cytiva.com. We look forward to hearing from you

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 www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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