The Regulatory Specialist is responsible for managing the coordination, preparation, and review of clinical regulatory documents, including the tracking and reporting of key performance by site and study. prepares and/or reviews submissions for clinical studies to local or central IRB/EC and regulatory authorities, as appropriate, in an ongoing manner maintaining compliance with local state/province or country laws and regulations.
Responsibilities:
- Supports study startup and regulatory activities, including but not limited to obtaining and maintaining regulatory and ethics approvals
- Creates master-level regulatory package for submissions for Regulatory Agencies
- Supports in-house regulatory submission(s) to Regulatory Agencies
- Supports creation of startup plans and essential documents checklists for assigned studies
- Prepares ongoing submissions and periodic notifications required by central and local IRB/EC, regulatory authorities, and other local regulatory authorities as needed; includes safety notifications as required by local laws/guidelines
- Reviews Master Informed ICFs to ensure all country-specific requirements are met
- Supports the development of country-specific ICFs as required by the protocols, utilizing translation vendors as necessary
- Creates essential document packages to sites and checks for completion
- Supports site submissions to local IRBs (provides site packages submits to central IRB)
- Confirms greenlight for site activation
- Initiates performance tracking (risk mitigation, corrective actions, lessons learned) for study
- Participates in study team meetings and provides start up status and regulatory approval updates
- Provides regulatory guidance to ensure compliance with applicable regulations and requirements
- Escalates regulatory, timeline, or other concerns to study team
- Maintains continuous awareness of local/country agency changes in regulatory processes, timelines, and required documentation
- Supports study teams during internal study audits and/or other process improvement activities
- Supports study teams for and/or during mock and actual inspections by regulatory authorities
Education and Requirements
- Bachelor’s Degree in a related field, or equivalent combination of training, education, and work experience
- At least 3 years of experience in a regulatory role in a pharmaceutical or CRO environment
- Extensive experience as site regulatory coordinator a plus
- Previous administrative work experience, preferably in an international clinical research setting
- Extensive knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
- Ability to demonstrate a high level of competency relating to administrative and clerical responsibilities, procedures, and systems
- Ability to handle confidential information and materials in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance
