Regulatory Manager

COMPANY DESCRIPTION

Charter Research is a highly experienced and quickly growing clinical research company, based in Florida and Illinois, that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is privately owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in Orlando .

POSITION OVERVIEW

The Regulatory Manager is responsible for overseeing the day-to-day operations of the Regulatory Team and providing leadership and hands-on support to the Team. The Regulatory Manager serves as a subject matter expert on regulatory processes and best practices, ensuring compliance with applicable guidelines and regulations. The Regulatory Manager is responsible for developing and maintaining efficient workflows that support high-quality documentation and regulatory readiness across all clinical trials.

RESPONSIBILITIES

1. Lead the Regulatory Team in all clinical trial activities and documentation in compliance with Food and Drug Administration (FDA) regulations and guidance documents, International Council on Harmonization – Good Clinical Practices (ICH-GCP), Charter Research SOPs, and relevant local and federal laws.
2. Establish, monitor, and refine performance metrics, as appropriate, to assess the regulatory department’s productivity, operational effectiveness, and compliance with applicable standards and requirements.
3. Communicate goals with Regulatory team at least monthly; motivate the team to achieve department and site objectives and provide coaching and feedback to support performance and development.
4. Standardize and define regulatory processes and workflows.
5. Develop written workflows, job aids, training materials and other materials related to regulatory processes that balance efficiency with FDA requirements.
6. Provide operational and administrative oversight of the eRegulatory system, including the implementation of system enhancements to improve departmental and site efficiency.
7. Communicate with and provide timely updates to study Sponsors, Site Leadership, the Compliance Team, and CRO representatives/monitors; address and resolve escalated regulatory concerns.
8. Ensure proper adherence to IRB guidelines to facilitate timely and effective communication with all Institutional Review Boards.
9. Assist with regulatory preparation for audits and FDA Inspections; proactively identify risks or gaps in documentation and implement corrective actions were appropriate.
10. Perform internal audits of regulatory files on an ongoing basis; exercise sound judgment to resolve issues within scope or escalate when needed.
11. Appropriately identify and prioritize issues or problems that need to be addressed by management, acting as needed.
12. Mentor and train team members and provide leadership and support to all department members; ensure team members complete required training; develop internal training materials, as needed. Support cross-training to improve team flexibility and operational resilience.
13. Collaborate with other site departments to ensure regulatory practices align with broader site goals and workflows and contribute to cross-functional efficiency.
14. Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; coaching and mentoring employees; addressing complaints and resolving problems. Responsible for the overall direction, coordination, and evaluation of the assigned department(s).

KNOWLEDGE, SKILLS, AND ABILITIES

1. Experience in managing, leading, and motivating a team.
2. Motivation to act as a champion to ensure data integrity, quality, and regulatory excellence.
3. Strong analytical, critical thinking, and writing skills, with proven ability to identify and implement process improvements in clinical research operations.
4. Expert communication and presentation skills, with experience, poise, and confidence to represent the company professionally to team, sponsors, CROs, and FDA inspectors.
5. Exceptional attention to detail and excellent organizational skills.
6. Display agility in handling multiple tasks simultaneously and adapting to changes in responsibilities and workloads.
7. Ability to travel to Charter Research’s site in The Villages, Florida, one day per week.

QUALIFICATIONS

Education & Experience

1. Bachelor’s degree preferred.
2. Typically, 3-5 years relevant experience or 2+ years of relevant experience in clinical research.
3. CCDM, CCRA, or CCRP (or equivalent) professional certification preferred.
4. Prior people management experience preferred.

PHYSICAL REQUIREMENTS

1. Prolonged periods of sitting at a desk and working on a computer.
2. Must be able to lift up to 15 pounds at times.

Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.