Description: prepare and process, with minimal supervision, all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. resolve, with minimal supervision, regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Specialist post-site initiation Skills: irb, regulatory, submission, adverse events, Clinical research, gcp, regulatory submission, oncology, Clinical trial, consent form Top Skills Details: irb, regulatory, submission, adverse events,Clinical research,gcp,regulatory submission Additional Skills & Qualifications: Bachelor's degree (preferably in a life science or human subject protection field) required and 2-3 years research experience required; at least 1 years regulatory experience preferred. Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred. Associated research credentialing (CCRP, CIP, etc.) preferred. Experience Level: Intermediate Level 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.
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