Regulatory Specialist

Company: Actalent
Location: Hackensack
Posted on: March 17, 2023

Job Description:

Position: Regulatory Affairs Associates Location: Hackensack, NJ - HYBRID Qualifications: 2 years of regulatory experience, experience with IRB submissions Therapeutic Area: Oncology. SUMMARY The Regulatory Specialist will serve as a regulatory liaison to internal and external investigators, sponsors, collaborating divisions, departments and institutions, and Institutional Review Boards (IRBs), Data Safety and Monitoring Boards, Biosafety committees, Laboratory facilities, and external regulatory agencies. The Regulatory Specialist is the primary point of contact and is responsible for the scheduling, preparation for and facilitation of conduct of all internal and external audits as well as ensuring ongoing compliance of study-related documentation throughout the clinical trial lifecycle for all assigned clinical trials.

• Organizes and maintains in audit ready condition at all times the regulatory binder (paper or electronic); files essential documents, obtains signatures for delegation logs, training logs and other essential study documents.
• Reviews sponsor template and site level Informed Consent Forms (ICF) to assure compliance with GCP and International Conference on Harmonization (ICH) guidelines. About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Hackensack , Regulatory Specialist, Other , Hackensack, New Jersey