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Regulatory Specialist

KPS Life -
Desde casa

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Detalles del empleo

Hace 3 días

Descripción completa del empleo

Opportunity Details

On Assignment Regulatory Specialist

Remote - Argentina

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

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