As Regulatory Support Specialist you will support Product Managers, Regions, and customers by providing quality documents and regulatory support for bioprocess products. You will add value by ensuring 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 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 issues, including necessary investigations, preparations and delivery of certificates, use of available internal and external 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.
Essential Requirements
* 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.
Preferred Qualifications
* Experience working in large matrix organizations.
* Fluency in the language of the country of employment.
* Experience in customer communication.
For questions regarding the role please contact hiring manager Henrik Norberg, Senior Manager Customer Regulatory Support, henrik.norberg@cytiva.com.
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