Regulatory Affairs Coordinator

Summary:

The Regulatory Affairs Coordinator (RAC) plays a vital role in ensuring compliance across all phases of clinical research. This position is responsible for managing every aspect of regulatory documentation and processes throughout the study lifecycle. The RAC prepares and submits IRB applications and amendments, maintains audit-ready regulatory files, and supports sponsor visits such as IMVs, SIVs, RMVs, and audits. By collaborating closely with project management, clinical operations, finance, business development, and quality & compliance teams, the RAC ensures adherence to GCP, IRB, and sponsor requirements while proactively addressing compliance risks. This role is critical to maintaining regulatory integrity and supporting the successful execution of clinical trials that advance safe and effective healthcare solutions.

Essential Duties and Responsibilities:

• Responsible for all regulatory activities throughout the study lifecycle.
• Prepares and submits IRB applications and amendments.
• Collects and maintains essential documents and training records.
• Prepares and reviews complex regulatory documents to ensure full compliance with FDA and other applicable regulatory requirements.
• Ensures compliance with GCP, IRB, and sponsor requirements.
• Supports and facilitates sponsor visits, including Site Initiation Visits, Monitoring Visits, and audits, by ensuring regulatory files are complete and audit‑ready.
• Supports study protocols and maintains accurate documentation essential for regulatory submissions, in alignment with clinical trial and medical device regulations.
• Tracks regulatory milestones, resolving outstanding items, and collaborating with project management, clinical operations, finance, business development, and quality & compliance teams to uphold regulatory integrity.
• Collaborates with internal teams and external agencies to ensure clear, timely, and accurate reporting of adverse events, demonstrating strong written and verbal communication skills.
• Identifies potential regulatory risks and develops appropriate mitigation strategies to support patient safety and product integrity.
• Stays current on evolving regulatory requirements and internal SOPs, ensuring proactive compliance and contributing to successful product approvals.
• Performs other duties as assigned.

Qualifications:

• Associate’s degree in life sciences, healthcare, or a related field (bachelor’s degree preferred); an advanced degree in a relevant scientific or regulatory discipline is beneficial. Relevant work experience may substitute for formal education.
• At least 3 years of experience in regulatory affairs within the clinical research or healthcare industry.
• Strong knowledge of FDA regulations and guidelines related to investigational drugs and devices.
• Experience preparing regulatory submissions and managing regulatory documentation.
• Excellent verbal and written communication skills.
• Experience with adverse event reporting systems and risk management processes.
• Familiarity with international regulatory requirements and standards, such as ISO 9001, ISO 13485, and EU MDR.
• Proven ability to work effectively in cross-functional teams and manage multiple projects simultaneously.

Certificates, Licenses, and Registrations:

• Regulatory Affairs Certification or equivalent credential (i.e. RAPS).

ACN does not provide visa sponsorship for this role. Candidates who will require immigration or visa sponsorship at any time now or in the future (including, but not limited to, H‑1B, TN, or STEM OPT training plans) are not eligible for this role.

About the Company:

At Alliance Clinical Network, our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health.