Regulatory Data & RIM Specialist

Pfizer; Bogotá; On-site; COP 60,000,000 - 120,000,000; Full time

Job summary

Pfizer is seeking a Regulatory Information Management (RIM) Coordinator in Bogotá to drive key activities within the Pfizer RIM system, enabling assessment and management of changes across the product lifecycle. You will coordinate events, registrations, and metadata to support GRS actions and content planning.

You will work with CMC Product strategists, labeling leads, and Regulatory Strategists, requiring deep knowledge of regulatory systems, master data, and lifecycle processes.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
• 4+ years of experience 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, including management of product/registration information in systems
• 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 RIM events and related records, ensuring registrations reflect product market records and master data standards.
• Interpret health authority communications, drive system updates, notify stakeholders, and collaborate with GRS, CMC strategists, PGS, and cross-functional teams.
• Review and approve data change requests, ensuring governance and regulatory compliance.
• Maintain active dossiers throughout the product lifecycle with ongoing accuracy and alignment to authority decisions.
• Train and support users on data quality standards and data management practices.
• Identify and implement solutions improving efficiency while supporting lifecycle processes.
• Ensure escalations and workflows meet business requirements and stakeholder needs.
• Drive continuous service improvement aligning processes with strategic objectives.

Skills

Regulatory data governance

Data management

Regulatory operations

Communication & collaboration

Attention to detail

Education

Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field

Job description

Pfizer is seeking a Regulatory Information Management (RIM) Coordinator in Bogotá to drive key activities within the Pfizer RIM system, enabling assessment and management of changes across the product lifecycle. You will coordinate events, registrations, and metadata to support GRS actions and content planning.

You will work with CMC Product strategists, labeling leads, and Regulatory Strategists, requiring deep knowledge of regulatory systems, master data, and lifecycle processes.