BioPharma Quality Regulatory Support Manager
GE Capital
Boston
40d ago

Role Summary :

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.

Essential Responsibilities :

  • 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
  • Qualifications / Requirements :

  • 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
  • Desired Characteristics :

  • Experience with biopharmaceutical process development and quality assurance
  • Expertise in the medical regulatory field
  • Experience leading cross-functional activities
  • Apply
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