Regulatory Data Coordinator

About the role

Pfizer's Vault RIM process depends on accurate and complete metadata, and health authorities are asking for more data to be tracked and submitted. The Regulatory Data Coordinator drives key activities in the Pfizer RIM system so that new or required changes can be assessed and managed. The role reviews events across the product lifecycle, completes system impact assessments, creates Activities, Regulatory Objectives and Submissions, and works with CMC Product strategists, labeling leads, Clinical and Country Regulatory Strategists.

Key responsibilities

• Manage all RIM events and related records, keeping them aligned with product market registrations, master data standards and health authority decisions
• Interpret health authority communications, update systems, notify stakeholders and work with GRS, CMC strategists and cross-functional teams
• Review and approve data change requests in line with data governance and regulatory requirements
• Maintain active dossiers throughout the product lifecycle
• Train business users on data quality standards and data management practices
• Create event details, impact assessment reports, and activities and records linked to impact assessments
• Facilitate Pfizer electronic and paper regulatory submissions, manage submission status and deliverables, and mitigate risks
• Lead or co-lead moderately complex projects, manage priorities and resource planning, and act as a subject matter expert in regulatory processes

Required profile

• Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Data Management or a related field
• 4+ years in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management or data quality role
• Product lead/support experience managing product and registration information in systems
• E2E global regulatory change management experience, including impact assessments, submission to health authorities and management of their decisions and queries
• Understanding of regulatory system structures, IDMP, CMC, artwork and labeling, and GRS roles
• Experience with master data management and data quality improvement

Required skills

• Detailed understanding of regulatory system structures and regulatory SME processes
• Proven technical aptitude and ability to learn new software, regulations and quality standards quickly
• Strong communication, collaboration, attention to detail and decision-making skills