Global ATMP Regulatory Lead: US/EU CMC & Analysis

PharmaLex Spain S.L.U.; España; A distancia; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

PharmaLex Spain S.L.U. in Spain seeks an experienced regulatory affairs professional with a background in pharmacovigilance and safety surveillance to lead client engagements and deliver compliant safety deliverables.

You will analyze safety data, support signal detection, and contribute to risk management across the product lifecycle while guiding junior colleagues in best practices.

Formación

• 4+ years of experience in Analytical/Cell & Gene Therapy Regulatory Affairs.
• Technical experience in ATMP/Gene therapy is required.
• Certification in regulatory affairs or quality management is preferred.

Responsabilidades

• Delivers client engagements and work products related to pharmacovigilance and safety surveillance.
• Coordinates case processing, documentation, reporting, and handoffs to support compliant safety deliverables.
• Analyzes safety data and literature to support signal detection and recommendations.
• Supports development of risk management deliverables across the product lifecycle.
• Guides less-experienced professionals in standards, documentation, and workflows.

Conocimientos

Pharmacovigilance

Safety surveillance

Risk management

Regulatory affairs

Educación

Bachelor's degree in life sciences or related field

Descripción del empleo

PharmaLex Spain S.L.U. in Spain seeks an experienced regulatory affairs professional with a background in pharmacovigilance and safety surveillance to lead client engagements and deliver compliant safety deliverables.

You will analyze safety data, support signal detection, and contribute to risk management across the product lifecycle while guiding junior colleagues in best practices.