Regulatory Support Specialist
We're looking for a Regulatory Support Specialist to join Cytiva's Customer Regulatory Support (CRS) team at our site in the UK. The role supports 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.
Responsibilities
* Build and maintain knowledge 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 a 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, including investigations, preparations, and delivery of certificates, using 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.
Qualifications
* Bachelor of Science degree in Chemistry, Pharmacy, or related field.
* Multiple years of experience in 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.
* Organized, accurate, and target-oriented, with a strong focus on quality and customer service.
* Flexible, service-minded, and able to collaborate effectively across teams.
Preferred Qualifications
* Experience working in large matrix organizations.
* Fluency in the language of the country of employment.
* Experience in customer communication.
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