CMC Specialist

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

• Authoring of CMC sections (Drug Product and/or Drug Substance) for new registration applications in CTD format, in alignment with global regulatory strategies and current regulatory guidelines.
• Authoring and reviewing CMC documentation to support variations and commitments resulting from interactions with Health Authorities.
• Partner with Global Regulatory Affairs (GRA) to support new registrations and worldwide post‑approval changes.
• Conduct Gap Analyses and/or Due Diligence assessments of the Quality sections of Global Dossiers.
• Ensure regulatory compliance of CMC sections for global products and drug substances throughout the product lifecycle.
• Evaluate the regulatory impact of quality-related change controls.
• Support QA in the qualification of Third Parties (CMOs).
• Prepare and/or publish eCTD sequences related to CMC content.

Job Requirements

Technical skills

• Degree in Relevant Scientific Discipline.
• At least 4 years’ experience in CMC. DP experience is preferable.
• Knowledge of relevant regulatory guidance’s.
• Knowledge of production (manufacturing, quality) and GMP compliance is value-added.
• Good knowledge of Microsoft Office package (Word, Excel, Power Point).
• Strong attention to detail, with the ability to manage multiple priorities effectively.
• Demonstrated teamwork capabilities, including adaptability to diverse working and communication styles.
• High level of initiative and autonomy in driving tasks forward.
• Flexibility and responsiveness in dynamic and changing environments.