Senior Regulatory Data Coordinator - Global Submissions

Pfizer; Ciudad de México; On-site; MXN 600,000 - 900,000; Full time

Job summary

Pfizer in Mexico City is seeking a Senior Regulatory Data Coordinator to drive RIM events, assess system impacts, and prepare regulatory submissions. You will ensure event details, change items, and labels are accurately linked and ready for action.

The role partners with GRS, CMC strategists, PGS, and other teams to maintain master data, monitor data quality, and train business users on governance standards.

Qualifications

• B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology (desirable).
• 2+ years of experience in regulatory, data management, data governance, or related role within the pharmaceutical or healthcare industry.
• E2E global regulatory change management experience, including change initiation, performing impact assessments, submission to HA and management of HA decisions/queries/interactions/commitments
• Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs and support compliance
• Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labeling
• Detailed understanding of GRS roles/responsibilities related to dossier maintenance and submissions
• Strong understanding of data governance principles and best practices.
• Experience with master data management and data quality improvement.
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
• Strong communication and collaboration skills.
• Attention to detail and commitment to data accuracy and integrity.

Responsibilities

• Manage all related RIM events and their related records, including event details and registered details – ensuring structures and relationships enable accurate reflection of the product market registration while still aligning to master data, and ensuring maintenance in alignment with agency decisions.
• HA Decision/Interaction management: interpret communications and drive appropriate actions to update system and notify stakeholders.
• Review and Approve Data Changes: Evaluate and approve data change requests, ensuring compliance with data governance policies.
• Active Dossier Management: Ensuring maintenance across the lifecycle, including alignment with agency decisions.
• Provide Training and Support: Train & support business users on data quality standards and data & process management best practices.
• Facilitate delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market.
• Collaborate with stakeholders across GRS & CMC strategists, PGS, and other teams to understand data requirements and ensure data needs are met.
• Evolve service based on strategic objectives – efficiency / quality drivers.
• Create Event Details, Run Impact Assessment Report, Create Related Records (activities) and verify accuracy.
• Monitor status and deliverables, identify risks and mitigate to ensure timely regulatory deliverables.

Skills

Strong communication

Collaboration

Attention to detail

Data governance

Education

B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology

Tools

Regulatory systems

Data quality tools

Job description

Pfizer in Mexico City is seeking a Senior Regulatory Data Coordinator to drive RIM events, assess system impacts, and prepare regulatory submissions. You will ensure event details, change items, and labels are accurately linked and ready for action.

The role partners with GRS, CMC strategists, PGS, and other teams to maintain master data, monitor data quality, and train business users on governance standards.