Data & Conformance Manager, Associate

Pfizer Inc; Bogotá; Hybrid; COP 120,000,000 - 180,000,000; Full time

Job summary

Pfizer Inc in Bogotá is seeking a Data & Conformance Manager within Regulatory Data & Conformance Management (RDCM) to interpret, manage, and ensure the quality and proper handling of global regulatory data across geographies and divisions.

You will ensure timely updates to regulatory systems, maintain data integrity for visibility across product lifecycles, and uphold SOPs to guarantee regulatory compliance.

Responsibilities

• Review and interpret the data provided by GRS to establish the system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Responsible for making updates in regulatory systems for all the CMC events upon receipt of notification of Submission and Approval evidence
• Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.
• Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance
• Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
• Assist in ensuring internal regulatory processes and procedures are well documented
• Support the teams in ADHOC activities including assisting presentations / review of metrics
• Makes timely decisions on straight cases within guidelines and policies

Job description

JOB SUMMARY

The Data & Conformance Manager focus within Regulatory Data & Conformance Management (RDCM) is to interpret, manage and ensure the quality, accuracy, and proper management of global regulatory data and conformance activities received across different geographies, functions and divisions. Ensuring key activities and regulatory systems updates are completed whilst adhering to all policies, practices and procedures. These activities ensure data integrity to enable the organization to have visibility across all functions within a products lifecycle. It is essential that all systems are clearly and accurately updated within the timelines specified in the Standard Operating Procedures (SOPs) or business process documentation to ensure regulatory compliance.

RESPONSIBILITIES

• Review and interpret the data provided by GRS to establish the system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Responsible for making updates in regulatory systems for all the CMC events upon receipt of notification of Submission and Approval evidence
• Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.
• Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance
• Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
• Assist in ensuring internal regulatory processes and procedures are well documented
• Support the teams in ADHOC activities including assisting presentations / review of metrics
• Makes timely decisions on straight cases within guidelines and policies

Work Location Assignment

Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.