Regulatory Affairs Lead - Clinical Quality & Compliance

Aequor Information Technologies Pvt. Ltd.; Ridgefield (CT); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Aequor Technologies LLC is seeking a Site Quality and Compliance Lead to drive quality and regulatory compliance across Phase I-IV trials and related programs in the US. The role emphasizes inspection readiness, training development, and cross-functional collaboration with US CDO, Legal, and Med/RA teams.

You will lead quality activities, monitor regulatory changes, implement CAPA plans, and ensure adherence to FDA, ICH, GCP, and internal SOPs while maintaining ethical standards and timely

Formación

• Knowledge of FDA/ICH/GCP regulations and SOPs.
• Ability to develop and deliver just-in-time training programs.
• Experience with CAPA, audits, and inspection readiness.

Responsabilidades

• Lead quality activities and inspection readiness.
• Ensure compliance with FDA/ICH/GCP and company policies.
• Develop and deliver training programs for US CDO.
• Coordinate quality initiatives with US CDO, Legal, and Med/RA.
• Prepare CAPA plans and address non-compliances in meetings.
• Report quality metrics and identify risks with mitigation plans.

Conocimientos

Pharma lifecycle process

Regulatory compliance

Tech trends

Educación

Bachelor's degree in life sciences

Descripción del empleo

Aequor Technologies LLC is seeking a Site Quality and Compliance Lead to drive quality and regulatory compliance across Phase I-IV trials and related programs in the US. The role emphasizes inspection readiness, training development, and cross-functional collaboration with US CDO, Legal, and Med/RA teams.

You will lead quality activities, monitor regulatory changes, implement CAPA plans, and ensure adherence to FDA, ICH, GCP, and internal SOPs while maintaining ethical standards and timely