Regulatory Data Specialist

Key Responsibilities: • Assess laboratory and manufacturing systems for alignment with data integrity and regulatory requirements • Lead or support structured compliance reviews and risk-based evaluations • Develop data flow documentation outlining system inputs, transformations, controls, and archival processes • Perform scheduled system oversight reviews in coordination with system owners • Evaluate audit trails and electronic record controls to ensure traceability and completeness • Author and revise SOPs, work instructions, and governance documentation • Support corrective and preventive actions tied to data integrity findings • Provide training and guidance on regulatory expectations related to electronic records and documentation controls • Partner cross-functionally with Quality, Operations, IT, and Validation teams • Maintain working knowledge of evolving global regulatory guidance Qualifications: • Bachelor’s degree in a scientific, engineering, or related discipline (experience may substitute) • Minimum 3 years in a GMP-regulated pharmaceutical, biotech, or medical device environment • Practical experience applying data integrity principles within laboratory or manufacturing systems • Familiarity with electronic records regulations (e.g., 21 CFR Part 11, EU Annex 11) • Exposure to system lifecycle management and/or computer system validation • Experience authoring and reviewing controlled documentation • Strong analytical skills with the ability to assess risk and drive resolution • Effective communicator with the ability to influence across departments