Summary: The Director of Regulatory is responsible for overseeing and directing all regulatory activities across a network of clinical research sites. This senior-level role focuses on developing and executing strategic regulatory initiatives to ensure compliance with FDA, GCP, ICH, and other relevant guidelines. The Regulatory Director leads the Regulatory Affairs Department, managing staff, collaborating with cross-functional teams, and fostering continuous improvement in quality assurance and compliance processes. They also play a critical role in external audits, regulatory submissions, and cross-departmental collaboration to drive operational excellence.

Responsibilities: The Director of Regulatory:

• Develops and implements regulatory strategies to ensure company-wide compliance with study protocols, government regulations, and industry standards.
• Monitors and interprets regulatory changes, assessing their impact on company operations and recommending adjustments as needed.
• Directs the preparation, submission, and tracking of regulatory documents, reports, and applications to relevant agencies.
• Ensures regulatory frameworks are in place and effectively communicated across the organization.
• Establishes and maintains professional relationships with federal, state, and local regulatory agencies.
• Leads, mentors, and manages a team of Regulatory Managers, Coordinators, and support staff.
• Oversees departmental hiring, training, and professional development to ensure a high-performing team.
• Plans, assigns, and reviews work, appraise performance, and address challenges within the department.
• Provides ongoing training for new and existing staff on regulatory requirements, company procedures, and industry best practices.
• Oversees internal and external audits, including sponsor and regulatory inspections, ensuring readiness and successful outcomes.
• Leads the development and implementation of Corrective and Preventive Actions (CAPA) and Root Cause Analysis (RCA) to address compliance gaps.
• Collaborates with Quality Assurance and Control teams to maintain up-to-date SOPs aligned with regulatory standards.
• Ensures proper retention and regular updates of personnel documentation, including CVs, certifications, and training records.
• Directs regulatory start-up and compliance activities across all sites within the network.
• Establishes guidelines for managing documentation in hard-copy and electronic formats, including E-Reg systems.
• Ensures timely updates and calibration of essential equipment, such as crash carts and temperature monitoring devices.
• Maintains oversight of site-specific portals to facilitate efficient access to regulatory and study-related information.
• Collects, analyzes, and report on key performance indicators (KPIs) for the Regulatory Department.
• Utilizes CTMS platforms and other compliance software to manage workflows, regulatory documentation, and reporting requirements.
• Oversees electronic data capture (EDC) processes and ensure proper integration with regulatory workflows.
• Coordinates with operations teams to align production design and development with regulatory standards.
• Assists the legal department with internal discoveries, depositions, and related compliance matters.
• Represents the company in external forums, such as Investigator and sponsor meetings.
• Occasional travel to company sites, Investigator meetings, and corporate events.
• Perform other duties as assigned by executive leadership.
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings.
• Performs other miscellaneous job-related duties as assigned by their manager or other management members.

Requirements:

• Minimum of 7-10 years of experience in regulatory affairs within clinical research, with strong knowledge of FDA regulations, ICH-GCP guidelines, and regulatory requirements.
• Prior experience managing and mentoring regulatory staff within a clinical or regulatory environment.
• Highlighted leadership experience and a proven track record in compliance and audit management.

Education:

• Bachelor’s degree preferred.
• Association of Clinical Research Professionals (ACRP) certificate preferred.
• Society of Clinical Research Associates (SOCRA) certificate preferred.

Competency Requirements:

• Excellent written and verbal communication skills
• Excellent analytical and problem-solving skills
• Strategic planning and organizational skills, with the ability to manage multiple projects simultaneously across a network.
• Proficient with Microsoft Office (or similar software) and CTMS platforms
• High level of personal motivation and initiative.

Technical Competency Requirements:

• In-depth knowledge of ICH/GCP guidelines for human research and understanding of CFR regulations.
• Familiarity with CTMS platforms, EDC systems, and both electronic and hard-copy documentation management.
• Extensive knowledge of government regulations relevant to clinical research.
• Understanding of Phases I-IV drug development processes.
• Ability to educate and inform management on regulatory compliance requirements.
• Proficiency in Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) planning for ongoing compliance improvements.

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting, standing or walking as required by the job.
• Ability to lift up to 20 pounds, and occasionally more.
• Occasional travel to company sites, investigator meetings, and sponsor-required meetings.

Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.