CMC Regulatory Writer - Global Submissions & Compliance

Italfarmaco; Alcobendas; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Italfarmaco is seeking an experienced candidate in Alcobendas, Spain to author and review CMC sections for drug registration applications. The role focuses on ensuring regulatory compliance and supporting quality assessments throughout the product lifecycle.

Ideal candidates will have at least 4 years of CMC experience, a degree in a relevant scientific discipline, and strong attention to detail. This position offers the opportunity to work in a dynamic environment with a focus on team collaboration and regulatory strategies.

Formación

• At least 4 years’ experience in CMC, with a preference for Drug Product experience.
• Knowledge of relevant regulatory guidelines and GMP compliance.
• Ability to manage multiple priorities and tasks independently.

Responsabilidades

• Author and review CMC sections for drug registration applications.
• Evaluate regulatory impact of quality-related changes.
• Support QA in qualifying Third Parties for CMC.

Conocimientos

CMC documentation authoring

Regulatory compliance

Teamwork

Attention to detail

Knowledge of Microsoft Office

Educación

Degree in Relevant Scientific Discipline

Descripción del empleo

Italfarmaco is seeking an experienced candidate in Alcobendas, Spain to author and review CMC sections for drug registration applications. The role focuses on ensuring regulatory compliance and supporting quality assessments throughout the product lifecycle.

Ideal candidates will have at least 4 years of CMC experience, a degree in a relevant scientific discipline, and strong attention to detail. This position offers the opportunity to work in a dynamic environment with a focus on team collaboration and regulatory strategies.