* Authoring of CMC sections (Drug Product and/or Drug Substance) for new registration applications in CTD format, in alignment with general 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 RequirementsTechnical 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. xqysrnh * Flexibility and responsiveness in dynamic and changing environments.

📌 CMC Specialist (Comunidad de Madrid)
🏢 ITALFARMACO
📍 Comunidad de Madrid