Regulatory Support Specialist

£22.1 - £25.8 per hourEstimated

Full-time

About Cytiva
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 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.
The Role
We’re looking for a Regulatory Support Specialist to join Cytiva’s Customer Regulatory Support (CRS) team at our site in UK. As Regulatory Support Specialist 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.
Multiple 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.
Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today. Please read our Applicant Data Privacy Notice carefully.

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Vacancy posted 28 days ago

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