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Sr Mgr, Regulatory Affairs

Baxter · Deerfield, IL

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RegulatoryFull-time$152k–$209kCompany career page

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Role summary

Senior Manager of Global Regulatory Affairs leads regulatory strategy development and execution for biologic/combination products across international markets. The role coordinates cross-functional teams on filings, compliance, and product lifecycle management while serving as strategic advisor to leadership on regulatory matters.

What they're looking for

  • Bachelor's degree in scientific discipline; Master's or PhD preferred
  • Minimum 7 years regulatory affairs experience
  • Expert regulatory knowledge with scientific training background
  • Management and leadership skills with ability to coach others
  • Strong oral and written communication and presentation abilities
  • Ability to manage multiple projects in matrix environment
  • Experience working in multinational and multicultural settings

What you'll be doing

  • Serve as global regulatory lead for hemostat and sealant biologic/combination products
  • Provide technical and strategic input on regulatory decisions aligned with business strategy
  • Monitor regulatory requirements, assess compliance, and implement mitigation plans for identified risks
  • Act as primary contact for regulatory authority meetings and manage complex projects
  • Mentor junior colleagues on US regulatory requirements and submission strategies

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Date posted4 days ago
Last source check1 day ago
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