KEY RESPONSIBILITIES
La descripción completa del puesto cubre todas las habilidades asociadas, la experiencia previa y cualquier cualificación que se espera que tengan los solicitantes.
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 e CTD 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.Fluent in English (B2 required).Good knowledge of Microsoft Office package (Word, Excel, Power Point). Soft skills:
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. xpzdshu Flexibility and responsiveness in dynamic and changing environments.