Regulatory Support Specialist

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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