Manager Research Regulatory Affairs

Sarah Cannon Research Institute•Nashville, TN

About The Position

As the Manager of Regulatory Affairs, you will oversee all aspects of the regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department. 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 Sarah Cannon 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. You will manage, directs, plan and schedule activities and programs for the regulatory department. You will 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. You will 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. You will 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. You will 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. You will resolve key regulatory issues with Pharmaceutical Industry Partners and Government Agencies. You will develop and implement an approved archiving system for study specific regulatory documentation and correspondence. You will apprise management of important regulatory issues and obtains guidance when necessary. You will attend network meetings, conference calls and monthly staff meetings as appropriate. You will visit strategic sites and provides training and mentoring as needed. You will provide proactive and creative recommendations on how to meet goals and handle identified deviations. You will be responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists. You will be responsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issues. You will initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects.

Requirements

A Bachelor’s Degree
Knowledge of scientific and clinical research terminology
Knowledge of FDA and GCP guidelines
Knowledge of organizational policies, procedures, and systems.
At least three years of experience in regulatory affairs
At least one year of experience in a supervisory role

Responsibilities

Oversee all aspects of the regulatory operations for Sarah Cannon Site Clinical Operations and manage the Regulatory Department.
Develop and implement short and long term strategies for the regulatory compliance for the site Clinical Operations.
Ensure Sarah Cannon adheres to and maintains Food and Drug Administration (FDA) regulatory compliance.
Oversee any regulatory audit.
Work closely with department directors and/or primary investigators, industry sponsors and other outside 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.
Manage and plan 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.
Manage the relationships between industry partners and the FDA regarding regulatory compliance for the organization.
Manage 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.
Be responsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs Specialists.
Be 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.