Regulatory Support Manager
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Uppsala
2019-12-19
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➡️ Klicka här för den senare publicerade platsannonsen "Regulatory Support Manager" (publicerad 2020-05-29) ⬅️
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hela Sverige Visa alla jobb hos GE Healthcare Bio-Sciences AB i Uppsala,
Danderyd,
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hela Sverige 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.
Essential Responsibilities:
As a member of the Customer Regulatory Support team, you will add value to bioprocess products and demonstrate a commitment to customer
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 web
Candidates should note that this role will be in scope for the proposed transition of GE Biopharma to Danaher and will transfer to Danaher at close of this transaction.
Qualifications/Requirements:
Bachelor of Science degree in Chemistry, Pharmacy or other related field or equivalent knowledge or experience
Strong 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
Strong ability to work independently, drive
Desired Characteristics:
Significant experience with biopharmaceutical or cell and gene therapy 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
For more information contact recruiting manager Ondina Åsberg +46 186120535 or
ondina.asberg@ge.com.
Welcome with your application!
Publiceringsdatum2019-12-19Så ansöker duSista dag att ansöka är 2020-01-15
Klicka på denna länk för att göra din ansökanAdressGE Healthcare Bio-Sciences AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare GE Healthcare Bio-Sciences AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Jobbnummer 5012789
Observera att sista ansökningsdag har passerat.