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Sr. Manager, Regulatory Information Management

Biogen
Full-time
Remote friendly (Cambridge, MA)
United States
$130,000 - $174,000 USD yearly
IT

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Role Summary

Sr. Manager, Regulatory Information Management (RIM) - oversee regulatory information management systems, partner with IT and business functions, and drive compliance and operational excellence within the regulatory ecosystem. Lead system ownership, upgrades, data curation projects, and daily global user support. Reports to senior leadership.

Responsibilities

  • Serve as the business system owner for one or more primary RIM capabilities
  • Partner with IT and business functions to deliver on the RIM roadmap
  • Lead and support system upgrade activities, ensuring compliance and operational excellence
  • Maintain and optimize RIM systems and related processes
  • Provide direct daily support to global users of regulatory systems
  • Lead smaller projects focused on data curation across multiple disciplines and processes
  • Collaborate with cross-functional teams to drive improvements and resolve issues
  • Document and communicate system changes and project outcomes
  • Ensure regulatory requirements are met in all system operations

Qualifications

  • Required: 8+ years in Pharmaceutical, Biotechnology, or Life Sciences with at least 5+ years focusing on Regulatory, and knowledge of Biopharma drug development and approval process
  • Required: 5+ years in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a GxP/Regulated Systems environment
  • Required: Subject matter expertise in applicable Regulatory Agency regulations (FDA/EMA, ICH, eCTD, IDMP) and best practices; IDMP experience highly preferred
  • Required: Familiarity with Master Data Management (MDM) and enterprise reporting capabilities (e.g., Tableau) is a plus
  • Preferred: Experience with data curation projects
  • Preferred: Familiarity with global regulatory environments
  • Preferred: Project Management skills and competencies

Skills

  • Regulatory systems expertise
  • Cross-functional collaboration
  • Data governance and data curation
  • Project management and stakeholder communication
  • Analytical thinking and problem solving

Education

  • Not specified
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