Regulatory Specialist II

Position Overview

The Regulatory Specialist II supports the planning, preparation, and maintenance of essential regulatory documentation required for clinical research studies. This role ensures compliance with federal, state, and local regulations, as well as KUR’s internal policies and procedures. The Regulatory Specialist II collaborates closely with Operations, Quality, and Compliance teams to ensure all regulatory activities are completed accurately and on schedule.

Key Responsibilities

• Prepare, submit, and maintain IRB submissions, including initial, continuing review, amendment, promptly reportable event, and closure documents.
• Maintain electronic Investigator Site Files (eISF), ensuring essential regulatory documents are current, complete, and compliant.
• Collaborate with Principal Investigators (PIs) and Clinical Research Coordinators (CRCs) to obtain required signatures, approvals, and certifications.
• Track and update investigator and staff credentials, medical licenses, CVs, and training certificates (CITI, GCP, etc.), ensuring timely renewals.
• Prepare study start-up documentation, including Form 1572, financial disclosure forms, delegation logs, and regulatory binders.
• Maintain and regularly update regulatory tracking logs and study status reports for active and pending protocols.
• Communicate directly with sponsors, CROs, and internal stakeholders to address regulatory queries and documentation requests.
• Review and document protocol deviations, ensuring proper reporting and follow-up under the supervision of the Senior Regulatory Specialist or VP of Compliance.
• Support the documentation and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) in accordance with GCP and protocol requirements.
• Participate in internal audits, monitoring visits, and sponsor inspections, ensuring regulatory readiness and documentation accuracy.
• Contribute to the development and standardization of regulatory templates, forms, and process workflows.
• Provide guidance and mentorship to Regulatory Specialist I or newly hired staff as assigned.
• Stay current with FDA, OHRP, and ICH-GCP regulatory updates affecting clinical research operations.
• Attend departmental and study start-up meetings to provide regulatory status updates and timelines.
• Perform other related duties as assigned.

Qualifications

• Bachelor’s degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field.
• 2–5 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.

Technical Skills

• Proficiency in Microsoft Teams, PDF Filler, DocuSign, SharePoint, and CTMS tools.
• Demonstrated ability to manage regulatory workflows in electronic systems, particularly CRIO.
• Strong attention to detail with the ability to maintain accurate, audit-ready documentation.

Job Type: Full-time

Benefits:

• Flexible schedule
• Health insurance
• Internet reimbursement
• Life insurance
• Provident Fund

Ability to commute/relocate:

• Sholinganallur, Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• regulatory experience in clinical research. : 2 years (Required)

Work Location: In person