Regulatory Affairs Associate

Description:

We are seeking a dedicated detail-oriented Regulatory Associate to join our team. This role is integral to maintaining regulatory documents, ensuring adherence to quality standards, FDA regulations and Good Clinical Practice (GCP) requirements, and supporting the Clinical Operations department in overall regulatory compliance. This role is responsible for the successful maintenance of regulatory documents and regulatory binders for clinical trials at the site.

Responsibilities:

Maintain compliance with local, state, ICH GCP, and FDA regulations in clinical trial regulatory operations.

Assist with day-to-day regulatory processes at the clinical site in collaboration with study teams, investigators, CROs, and sponsors.

Ensure timely filing of essential Regulatory documents in the Investigator Site File (ISF), including routine correspondence.

Assist with documentation of study specific training for clinical trials.

Support preparations for and follow-up to routine monitoring visits.

Provide responsive and diligent collaboration with sponsor/CRO clinical and regulatory study teams, including prompt resolution of pending action items.

Conduct regular quality checks of regulatory documents in the company drive and CTMS ensuring that regulatory binders/files are current, accurate and audit ready.

Foster effective and professional engagement with staff and providers.

Qualifications:

Bachelor’s degree in Life Sciences or a related field is a plus but not required.

1+ years of experience in clinical research regulatory affairs is preferred for the regulatory associate position

Some knowledge of FDA regulations, ICH-GCP guidelines, IRB processes, and clinical trial protocols.

Regulatory experience with Central IRB(s) is preferred.

Knowledge of regulatory and medical terminology, clinical trials and GCP concepts.

Detail oriented and meticulous in all aspects of work with a focus on accuracy and compliance.

Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.

Ability to work well independently as well as in a team environment

Excellent written and verbal communication skills.

Strong interpersonal, customer service and multi-tasking skills are critical

Must be proficient in databases used in research environment or have a willingness to learn and demonstrate proficiency.

Possess the ability to work well under pressure, multi-task, and manage deadlines