Regulatory Labeling Manager — Lifecycle Products (Remote)

Syneos Health, Inc.; España; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to oversee labeling content for mature pharmaceutical products. You will author and update labeling documents in response to safety updates, regulatory requirements, and internal assessments, ensuring governance and documentation compliance.

Collaborate with Safety, Medical, Legal and Regulatory Strategy teams; support health authority inquiries; prepare materials for eCTD submissions; ensure timely, submission-ready

Formación

• Experience drafting and maintaining labeling content for approved products.

Responsabilidades

• Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
• Author and revise labeling documents including CCDSs, USPI, SmPC, and ROW labels for lifecycle products.
• Support labeling governance by coordinating with team lead and ensuring timely minutes and approvals.
• Ensure labeling content complies with FDA, EMA, ICH and internal standards.
• Collaborate with Safety, Medical, Legal and Regulatory Strategy teams to gather input on labeling changes.
• Support responses to health authority queries related to labeling content.
• Partner with document specialists to ensure submission-ready formatting and timely delivery.

Conocimientos

Regulatory labeling knowledge

Labeling authoring

English proficiency

Attention to detail

MS Word

Communication skills

Educación

Bachelor's degree in Science or Business

Herramientas

Veeva Vault

Intagras

Veeva Labeling

Descripción del empleo

Syneos Health is seeking a Regulatory Labeling Manager – Lifecycle Products to oversee labeling content for mature pharmaceutical products. You will author and update labeling documents in response to safety updates, regulatory requirements, and internal assessments, ensuring governance and documentation compliance.

Collaborate with Safety, Medical, Legal and Regulatory Strategy teams; support health authority inquiries; prepare materials for eCTD submissions; ensure timely, submission-ready