Regulatory Specialist

The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP), and Institutional policies. The Regulatory Specialist will serve as a liaison to investigators, collaborating divisions, departments, and institutions, the Institutional Review Board (IRB), and external regulatory agencies. Key responsibilities include organizing and maintaining the regulatory binder, reviewing Informed Consent Forms (ICF) for compliance, participating in regulatory reviews, ensuring timely submissions to the IRB, and acting as a liaison between investigators and regulatory bodies. The role also involves preparing regulatory documentation for audits, attending study team meetings, and staying abreast of developments in GCP and federal regulations. Additional duties include orienting new staff, assisting in the development of compliance procedures, and maintaining awareness in clinical research through ongoing education.

Requirements

2+ years clinical trial regulatory experienceIRB and GCP experienceMaintaining components of clinical trialBachelors degree preferredSoft SkillsLiaison capabilitiesAttention to detailProblem-solvingEffective communicationTeam participationTimely follow-upIssue resolutionResourcefulnessAdaptability in high-pressure environments
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.