Be responsible for supporting Product Managers, Regions and customers by providing quality documents and regulatory support in response to customers’ requests for quality, regulatory and technical-related information. Provide regulatory support in ongoing projects, product care activities, and change control. As a member of the Customer Regulatory Support team, add value to bio-pharmaceutical customers’ single-use products and demonstrate a commitment to customer satisfaction.
• 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
• Contribute in project teams as regulatory support expert
• Participate in change control activities, including writing and releasing formal change control notifications
• Lead cross-functional activities when required
• Respond efficiently and promptly to customers’ regulatory based issues, which will include necessary investigations, preparations and delivery of certificates, use of internal and external databases
• Prepare, update and review regulatory support documentation, including Validation Guides, change control notifications, statements, certificates and other regulatory related documentation for new and existing products
• Use existing web based system and expand regulatory supporting information provided on the web
• Bachelor of Science degree in Chemistry, Pharmacy or related field
• Three or more years of experience in quality, product management or a related field
• Understanding of GMP and knowledge of regulatory requirements in the BioProcess industry
• Organized, accurate, target oriented, quality minded and customer oriented
• Strong written and verbal communication skills
• Flexible and service-minded with the ability to be collaborative
• Driven with strong ability to work independently
• Experience with biopharmaceutical process development and quality assurance
• Expertise in the medical regulatory field
• Experience leading cross-functional activities
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE Healthcare Life Sciences :: There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
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