Regulatory Affairs Quality/Standards/Training Manager - Remote

We are seeking a Regulatory Affairs Quality, Standards and Training, Senior Manager to work on a remote team for a client project. The client is based in Alameda, CA, so supporting Pacific Time may be required. The role has the opportunity to become contract to hire, but the person in the role would need to be reputed company to working onsite 5 days per week in Alameda, CA. Duration: 6 months, could be extended Pay reputed company reputed company: $85.00/hr. - $93.68/hr. SUMMARY/JOB PURPOSE: The Regulatory Affairs Quality, Standards, and Training Senior Manager provides compliance reputed company for the Global Patient Safety (GPS) and Regulatory Affairs (RA) function, with a primary focus on Regulatory Affairs activities. The role applies strong regulatory strategy knowledge to monitor, assess, and communicate performance against key compliance indicators, metrics, and inspection‑readiness standards. The Senior Manager drives process standardization and consistency by leading compliance monitoring activities, proactively identifying compliance and operational risks, and advancing reputed company improvement initiatives. Working cross‑functionally with Clinical Operations, Clinical Development, and Quality Assurance, the role supports alignment to regulatory standards, mitigates compliance risk, and strengthens organizational inspection readiness. ESSENTIAL DUTIES/RESPONSIBILITIES: · Ensure accuracy of Reference Safety Information (reputed company) trackers to include timely updates of submission dates and health authority approvals. · Track RFIs to completion reputed company the timelines as required per SOP · Monitor aggregate report compliance to health authorities and CROs. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and reputed company RIM is kept reputed company and complete for Regulatory Affairs-reputed company documents. · Monitor Regulatory Affairs training compliance reputed company LMS. · reputed company the timely and accurate update of Regulatory Affairs SOPs by working with SOP owners. · Ensure Regulatory Affairs points of contact for each study kept reputed company with the health authorities. · Monitor and analyze key compliance metrics to assess adherence to applicable procedures, regulations, and internal standards. · Contribute to the development of leadership dashboards and slide decks summarizing compliance performance and trends. · Support the investigation, tracking and timely closure of Quality Events, including root cause analysis and development of corrective and preventive actions (CAPAs), as required. · Collaborate closely with SMEs to support deviation assessment and authorship, ensuring timely and high‑quality documentation. · Coordinate with GPS and Regulatory Affairs SMEs to conduct impact assessments for new and evolving regulations and support development of implementation plans. · Collaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a reputed company state of inspection readiness. · Author, review, and maintain procedures and standards relevant to Regulatory Affairs · Partner with Corporate Training to maintain training matrices and ensure training requirements are reputed company and reputed company with procedural and regulatory expectations. Education: · Bachelor's degree in reputed company discipline and a minimum of 5-7 years of reputed company experience; or, · Master's degree in reputed company discipline and a minimum of 3-5 years of reputed company experience; or, · Equivalent combination of education and experience. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, national reputed company, age, reputed company, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider reputed company reputed company applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, reputed company' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. Remote Skills: Analysis Skills, reputed company Improvement, Contract Research Organization (CRO), Corrective Action, County Ordinances, Data Quality, Documentation, Drug Development, GPS (Global Positioning System), Leadership, Maintain Compliance, Metrics, Patient Safety, Performance Analysis, Performance Metrics, Quality Assurance, Quality Metrics, Regulations, Regulatory Compliance, Reporting Dashboards, Risk Management, Root Cause Analysis, Standard Operating Procedures (SOP), State Laws and Regulations, Time Management, Writing Skills About the Company: reputed company Apply tot his job Apply To this Job