Research Regulatory Specialist III

• The Research Regulatory Specialist III provides regulatory support to the research team by conducting all the tasks and activities of the Research Regulatory Specialist I and has the additional responsibilities of assisting the Research Regulatory Specialist III to support Research Institute research investigators with investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA.

• This role also coordinates the regulatory activities led for multi-site research protocols.

• The Specialist functions as a liaison between the IRB, the FDA, investigators, study teams, sponsors, CROs, OSP, COI office, clinical research department managers, and leadership.

• Key responsibilities include assisting with the submission of research protocols and other required documents to the FDA, providing data and document collection for regulatory filing, coordinating regulatory processes and submissions for multi-site research, and preparing and submitting new research protocols and informed consent documents.

• The Specialist ensures all regulatory documents comply with Federal regulations, ICH/GCP guidelines, and AAHRPP standards.

Hard Skills

• Bachelors degree

• Must be certified in SOCA or ACRP

• 2+ years regulatory experience

• Full cycle regulatory experience (start up, maintenance, and close out)

• Oncology experience

Job Type

This is a Contract-to-Hire position with a duration of 6 Month(s).

Work Environment

100% Remote

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.