Location(s): United States; Massachusetts; Marlborough
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Role Summary: The Regulatory Support Manager will have responsibility 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 biopharmaceutical 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
Participate in project teams as regulatory support expert
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 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, HWPD, CCN, 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 Bonus Target Information - Country US Bonus Target Information - IFG GE Healthcare Daily Work Schedule - Friday 8 Daily Work Schedule - Monday 8 Daily Work Schedule - Saturday 0 Daily Work Schedule - Sunday 0 Daily Work Schedule - Thursday 8 Daily Work Schedule - Tuesday 8 Daily Work Schedule - Wednesday 8 web
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Bachelor of Science degree in Chemistry, Pharmacy or other related field
Three or more years of experience in the (bio)pharmaceutical industry or a related field
Understanding of GMP and knowledge of regulatory requirements in the (bio)pharmaceutical industry
Organized, target and customer oriented
Strong written and verbal communication skills
Flexible and service-minded with the ability to be collaborative
Strong ability to work independently
Five or more years’ experience with biopharmaceutical process development and quality assurance
Expertise in the medical regulatory field
Experience in GE Healthcare product development or production.
Experience leading cross-functional activities
Strong computer skills with prior experience in systems, including Microsoft Office products, Magic, Oracle and Lotus Notes
Locations: United States; Massachusetts; Marlborough
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