Manager of Regulatory Affairs - Remote US

Sarah Cannon Research Institute•Work at Home - Tennessee, USA (WTNA), TN

23h•Remote

About The Position

The Regulatory Affairs Manager oversees regulatory operations for Sarah Cannon Research Institute site Clinical Operations and manages the regulatory department. The role develops and implements short- and long-term strategies for regulatory compliance, ensures adherence to FDA requirements, and oversees regulatory audits. It works closely with department directors, primary investigators, industry sponsors, and other external entities. This is a remote position based in the United States. Relocation assistance and visa sponsorship are not available.

Requirements

Bachelor's degree.
At least 1 year of work experience; 5 or more years is preferred in a clinical research corporation and regulatory team. Education may substitute for partial experience.
Knowledge of scientific and clinical research terminology.
Knowledge of FDA and GCP guidelines.
Knowledge of organizational policies, procedures, and systems.
Advanced skills with Microsoft Office products, including Excel, Word, and Outlook.
Experience meeting strict deadlines and supervising team members.

Nice To Haves

Five or more years of experience in a clinical research corporation and regulatory team.

Responsibilities

Manage, direct, plan, and schedule activities and programs for the regulatory department.
Establish and enforce procedures to ensure trial teams and sites comply with applicable laws, regulations, SOPs, and other guidelines.
Develop and implement regulatory policies and procedures for sites and site Clinical Operations, including planning and managing regulatory compliance for industry sponsors and/or sites.
Manage regulatory affairs across multiple clinical trials in accordance with FDA and GCP guidelines for individual sites, studies, sponsors, and/or networks.
Manage relationships between industry partners and the FDA regarding organizational regulatory compliance, and manage regulatory audits conducted by sponsors, industry partners, and governmental auditors.
Perform other duties as assigned.