Regulatory Data Governance Coordinator

Position

Regulatory Data Governance Coordinator

Poland

The Regulatory Data Governance Coordinator will ensure Regulatory information and data standards are aligned with Client's strategic business requirements (e.g., MDM, Regulatory strategy, Industry standards, HA expectations). Working closely with the Management team and key stakeholders, he/she will assist the team in integrating data assets from a variety of systems and sources into Company’s RIM systems, ensuring and monitoring the final quality of our internal data stores and flows.

• Oversee the establishment and execution of Regulatory data governance policies.
• Oversee data quality process operations, assign available resources, track and report on progress of key data initiatives.
• Report on data quality metrics to key stakeholders and management.
• Engage with standard data governance roles (Data Quality Analyst, Data Stewards, Data owner) for the regulatory data domain.
• Maintain the Regulatory Data Catalog:
  Document data classification and quality rules.
• Oversee Regulatory Document data classification rules, compliance/retention rules, and business rules and access policies.
• Lead efforts in defining appropriate metrics to measure the quality of the metadata relative to usability and compliance with internal and regulatory policies.
• Define process, frequency, and responsibility for identification of metadata discrepancies and resolution.
• Ensure that the metadata framework captures all relevant metadata needed for regulatory needs as well as data management compliance.
• Drive adoption of metadata management practice through training and effective change management across stakeholder groups.
• Participate in forums (with other domain trustees/stewards, etc.) to communicate change management and address specific issues related to their domain and business unit.
• Support Change Management and Regulatory Intelligence assessment processes to evaluate impact on Regulatory Data.
• Assess impact of system changes on data governance assets.
• Support definition of RIM data Roadmap, RIM Architecture diagrams, Interface Specifications as SME.

• 5+ years of experience in the Healthcare/Pharmaceutical industry.
• 5+ years of relevant work experience in data management/data governance role.
• Strong experience and advanced understanding of the collection and management of regulatory data and regulatory documents (5+ years).

• Desire to be a hands‑on contributor, pro‑active and able to drive direction of work that needs to be completed.
• Knowledge of Metadata Management and Master Data Governance best practices.
• Ability to identify, analyze and address problems to resolve issues whenever possible in a way that minimizes negative impact and risk to the organization.
• Familiarity with Data Catalog and Data Management Tools (Collibra or other).
• Understanding of Pharmaceutical Data Standards; US and International (ISO, ICH, IDMP, SPOR, EDQM, XEVMPD, PQ CMC…).
• Analytical/problem‑solving skills.
• Familiarity with Veeva RIM Data Model.
• Experience with Labeling, CMC and Regulatory processes.
• Experience implementing technology solutions either as a project, technical, or functional lead.
• Experience with public and hybrid cloud environments.
• Experience working in a GxP environment preferred.

Mid‑Senior level

Full‑time

Other

Pharmaceutical Manufacturing