Regulatory Specialist

As a Regulatory Specialist, you will be responsible for the following key responsibilities: - Bachelor's degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field. - 25 years of regulatory experience in clinical research or pharmaceutical environments. - CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within two weeks of hire; training will be provided. - Familiarity with IRB submissions, study start-up activities, and regulatory document maintenance. - Proficiency with CRIO (Clinical Research IO) or similar electronic platforms used for eISF and study documentation. - Experience with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) platforms, and eISF systems. - Working knowledge of FDA, OHRP, and ICH-GCP guidelines. - Prior experience supporting sponsor or FDA audits/inspections. - Strong organizational, communication, and time-management skills. - Ability to work independently and manage multiple priorities. You will need to have a Bachelor's degree in a relevant field and at least 7 years of experience in regulatory affairs within clinical research or pharmaceutical settings. Additionally, you must possess CITI certifications and have proficiency in various electronic platforms used for study documentation. Your familiarity with regulatory guidelines and ability to support audits will be crucial in this role. Strong organizational and communication skills are essential for success, along with the ability to work independently and prioritize tasks effectively.,