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Top Regulatory Affairs Executive

Directs and oversees activities that implement policies relating to regulatory affairs. Develops and coordinates internal policies and directives to ensure organizational compliance with regulations.: Advises on and coordinates the formation of organization's position on regulatory affairs. Develops strategies and programs necessary for regulatory approval of organization's products and/or services. Assures that organization is aware of regulations affecting its operations. Keeps informed on local, regional, and national regulations, policies, and legislation. Monitors proposed legislation and regulations for possible impact and effect on the organization. Plans and conducts campaigns toward attaining organizational goals under the direction of the CEO. Meets with regulators and other external parties to resolve grievances and/or advance positions. Provides regulatory advice to teams on assigned projects. Plans content and timelines of regulatory documents and ensures alignment with agreed strategy. Identifies and resolves regulatory issues with relevant departments or office. Communicates with regulatory authorities to expedite review and approval.

Regulatory Affairs Analyst

Monitors and analyze issues in various phases of government regulatory procedures to identify trends important to the organization for use by management in decision making. Provides analysis and background material in responses to regulations, policies, and legislation. Participates in the development of organizational strategy to address regulatory affairs.: Reviews and edits materials to meet regulatory requirements and organization policy. Reviews newsletters, articles, government publications, and other reports for background information on relevant topics. Develops and prepares data required for submission to regulatory bodies. Serves as liaison to task forces, committees, and work groups as assigned. Interfaces with key staff members in Strategic Planning Department, Product Development, Operations, Legal, and Customer Service Departments to meet scheduled submission dates. Communicates with representatives of Federal and State agencies and other outside organizations on issues related to the organization. Establishes and maintains relationships with appropriate organizations in the private sector to obtain information on subject areas of interest, and attends selected meetings on relevant topics. Participates in development, analysis, and report writing for the organization. Advises on the organization's position on proposals and assists in implementing the internal communications program regarding government legislation that affects the organization's operations. Monitors proposed legislation and regulations for possible impact and effect on the organization. Advises department manager when significant deviations occur from planned submission schedule or when product, testing, labeling, or service will be unlikely to meet regulatory requirements. May meet with government officials and other external parties to resolve grievances and/or advance positions. May represent the Regulatory Affairs Department in monthly legal process review.

Regulatory Agency Director

Directs agency, division, or major function of agency or division charged with investigating regulated activities to assure compliance with federal, state, or municipal laws: interprets and clarifies federal, state, or municipal laws. Represents agency at meetings, conventions, and other forums to promote and explain agency objectives. Consults with other governmental agencies, business community, and private organizations to resolve problems. Plans and directs surveys and research studies to ensure effective program operation and to establish or modify standards. Recommends changes in legislation and administrative procedures to reflect technological and ecological changes and public sentiment. Confers with legislative liaison individuals or committees to develop legislative bills involving inspection procedures and to obtain wording for proposed inspection codes. Prepares or directs preparation and release of reports, studies, and other publications relating to program trends and accomplishments. Reviews and evaluates work of manager, regulated program through conversations, meetings, and reports. Prepares or directs preparation of budget requests. May be required to testify in court or before control or review board. May be designated according to function or agency administered as administrator, pesticide; administrator, structural pest control; agricultural commodity grading supervisor; director, reactor projects; director, transportation utilities regulation (governme.

Regulatory Affairs Manager

Manages and coordinates staff in various phases of government relations and plans, and conducts campaigns under the direction of Top Governmental Affairs Officer or Director toward attaining company goals. Advises on, and coordinates the formation of, organization's position on proposals. Ensures compliance of all programs regulated by the government. : Implements internal communication program regarding government legislation that affects the organization's operations. Monitors proposed legislation and regulations for possible impact and effect on the organization. May meet with government officials and other external parties to resolve grievances and/or advance positions.

Regulatory Administrator

Directs and coordinates activities of workers engaged in investigating and responding to complaints from utility service subscribers or regulatory agencies concerning rates and services. Directs investigations of utility company rates and services to ensure that subscribers' complaints are answered and requirements of governmental utility-regulation agencies are met. This position typically reports to a manager and is the first level of supervision in the organization.: Analyzes reports of resulting data, and recommends response to complaint, considering nature of complaint and company interests and policies. Directs preparation of documents for use by company witnesses summoned to testify at governmental hearings. Reviews governmental rulings to determine changes in legal stipulations and probable effects on company activities. May provide advice and source data to management personnel concerned with preparing applications to regulatory bodies for changes in rates or service.

Utility Regulatory Administrator

Assistant Project Manager

Works with the Project Manager and other management to ensure that structured processes are in place and objectives are accomplished within prescribed time frame and funding parameters. Manages the project team's work efforts in harmony with competing priorities within company. Provides leadership and guidance to assigned projects.: Gives work direction, prepares schedules, and sets deadlines to ensure timely completion of work. Identifies issues for early resolution. Determines and selects corrective action and workaround solutions whenever deviations from project plan are identified. Informs Project Manager and appropriate management of issues and remediation plans. Ensures compliance to all applicable safety and health rules and regulations, company policies, and procedures. Provides Project Manager with recommendations for improving tracking, reporting, and monitoring of projects. Assists in preparation of periodic management reports. May attend meetings on behalf of Project Manager. May train staff, evaluate performance, and recommend or initiate promotions, transfers, and disciplinary action.

Clinical Project Manager

Manages projects to achieve goals within budget, on schedule, and in compliance with the Food and Drug Administration, International Conference on Harmonisation, World Health Organization's Good Clinical Practices, and other applicable regulations. Designs, communicates, and implements clinical development plans and timelines for clinical research projects. Coordinates activities of associates, CRO's, and investigators to ensure compliance with protocol, overall clinical objectives, and applicable regulations.: Assures integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, and medical records. Gathers metrics from all functional areas to identify and manage milestones and risks to project. Develops a risk management and mitigation plan and holds each functional group, within the project team, accountable for managing and executing to that plan. Develops and makes presentations that could lead to expanded business opportunities. Participates in proposal efforts and sales calls to enhance opportunities for future business deals with clients. Represents the company at investigator meetings. Serves as a clinical resource to Sales, Product Development, and Marketing Departments. Presents clinical information at various meetings and professional education seminars. Prepares, reviews, and revises necessary clinical documents, such as protocols, guideline informed consent forms, investigator brochures, study operations manuals, study and safety reports, and clinical sections of annual reports. Maintains confidentiality of study protocols and subjects. Ensures security of all radiographic images and study and regulatory documents. Evaluates and participates in selection of consultants, CRO's, and other vendors, and studies sites to perform clinical research activities. Identifies cost and schedule variances, and develops and implements corrective actions for negative variances. Selects and hires employees, and trains and evaluates them to enhance their performance, development, and work product. May negotiate contracts with investigational sites and laboratories for content and pricing, ensuring that all regulations and legal requirements are met. May travel to field sites to supervise and coordinate clinical studies.

Clinical Trial Manager

Oversees the development of clinical trials, including protocol development, site selection, timeline and budget management, monitoring, safety reporting, clinical supplies maintenance, collection of data and regulatory documents, data analysis, and preparation of study reports. Provides leadership, guidance, and clinical trial management expertise to in-house and contract staff. : Leads in identifying overall resourcing needs for projects. Defines site qualification criteria and oversees the identification of potential investigators and clinical sites. Assesses study drug requirements and shipment logistics. Manages the writing and review of protocols, case report forms, and study reports. Assists the medical monitors during the preparation of study reports. Develops clinical monitoring plans and studies monitoring priorities. Manages studies to ensure they are conducted in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. Oversees and participates in initiation, monitoring, and closeout visits as well as review of reports and follow-up to identify and resolve site issues. Identifies data deficiencies and discrepancies, and coordinates corrective action as required.

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