Sr. Quality/Regulatory Manager

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  • Prepare FDA submissions for new products and product changes, as required, to ensure timely approval for market release
  • Execute regulatory strategies/plans
  • Provide ongoing support to product development teams for regulatory issues/questions
  • Coordinate with vendors and marketing on preparation of new packaging artwork, and review revisions to packaging artwork for compliance with approved labeling
  • Perform and direct quality system internal audit activities and drive improvements within the local quality system
  • Ensure regulatory affairs files are maintained to support compliance with regulatory requirements
  • Handle audit planning, conduct, findings, responses, and corrective and preventative actions
  • Direct quality management sub-systems to achieve compliance and consistency in management reviews, CAPA, design change, document control, validation, process control, complaints, training, etc.
  • Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
  • Responsible for providing performance feedback to direct reports as well as coaching and assistance in their development
  • Assist in the identification and management of departmental project and personnel issues.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedure
  • Other responsibilities as required or assigned by manager



  • 8 plus years of management experience in a manufacturing setting
  • 5 plus years of FDA and cGMP experience required
  • Bachelor’s degree or equivalent work experience
  • Strong leadership ability, project management and team facilitation skills
  • Strong communication skills and can work well with others
  • Knowledge of MS Word, Excel, Outlook and other computer programs 
Location: Buffalo, NY
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