Regulatory Data Coordinator, Sr. Associate

About the role

Pfizer is looking for a Senior Associate Regulatory Data Coordinator to drive key activities in its Vault RIM process and system, which depends on accurate and complete metadata. The role reviews events across the product lifecycle, completes impact assessments and creates activities, regulatory objectives and submissions so that GRS can act, and prepares the Global Content Plan for content authoring.

Key responsibilities

• Manage RIM events and their records, keeping structures aligned with product market registration and master data, and maintaining them in line with agency decisions
• Interpret agency communications and drive updates to the system, collaborating with GRS, CMC, PGS and other teams on data requirements
• Review and approve data change requests in line with data governance policies
• Maintain dossiers throughout the lifecycle and support delivery and approval of electronic and paper regulatory submissions, including CMC components
• Identify risks to quality and timeliness of CMC changes and partner with regulatory strategists to mitigate them
• Train and support business users on data quality standards and data and process management best practices
• Generate reports on data quality, data requests and other metrics, and send notifications to stakeholders after data updates
• Create event details, run impact assessment reports and create activities and related records using the wizard, then verify accuracy and linkages
• Contribute to moderately complex projects, plan short-term work and escalate issues to meet business needs

Required profile

• Bachelor's degree in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant experience considered
• 2+ years of experience in regulatory, data management, data governance or a related role in the pharmaceutical or healthcare industry
• E2E global regulatory change management experience, including change initiation, impact assessments, submission to health authorities and management of agency decisions and queries
• Detailed understanding of regulatory system structures, regulatory SME processes (centralized registration, IDMP, CMC, artwork/labelling) and GRS roles and responsibilities
• Strong understanding of data governance principles, master data management and data quality improvement
• Proven technical aptitude, quick learning of new software and regulations, and strong communication and attention to detail