Manager Research Regulatory Affairs

You will be responsible for developing and implementing short- and long-term strategies for the regulatory compliance for the site Clinical Operations.

You will ensure SCRI adheres to and maintains Food and Drug Administration (FDA) regulatory compliance as well as oversees any regulatory audit.

You will work closely with the department directors and/or primary investigators, industry sponsors and other outsides entities.

• Manage, direct, plan and schedule activities and programs for the regulatory department
• Establish and enforce procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, standard operating procedures (SOPs), and other applicable guidelines
• Develop and implement regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sites
• Manage the regulatory affairs between the organization for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines; for individual sites, studies, sponsors and/or other networks
• Manage the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors
• Resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies
• Develop and implement an approved archiving system for study specific regulatory documentation and correspondence
• Apprise management of important regulatory issues and obtains guidance when necessary
• Attend network meetings, conference calls and monthly staff meetings as appropriate
• Visit strategic sites and provides training and mentoring as needed
• Provide proactive and creative recommendations on how to meet goals and handle identified deviations
• Responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists
• Responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issues
• Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects