PbKEY RESPONSIBILITIES /b /pulliAuthoring 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. /liliAuthoring and reviewing CMC documentation to support variations and commitments resulting from interactions with Health Authorities. /liliPartner with General Regulatory Affairs (GRA) to support new registrations and worldwide post‑approval changes. /liliConduct Gap Analyses and/or Due Diligence assessments of the Quality sections of General Dossiers. /liliEnsure regulatory compliance of CMC sections for global products and drug substances throughout the product lifecycle. /liliEvaluate the regulatory impact of quality-related change controls. /liliSupport QA in the qualification of Third Parties (CMOs). /liliPrepare and/or publish eCTD sequences related to CMC content. /li /ulpbr/ppbJOB REQUIREMENTS /b /ppbTechnical skills: /b /pulliDegree in Relevant Scientific Discipline. /liliAt least 4 years’ experience in CMC. DP experience is preferable. /liliKnowledge of relevant regulatory guidance’s. /liliKnowledge of production (manufacturing, quality) and GMP compliance is value-added. /liliFluent in English (B2 required). /liliGood knowledge of Microsoft Office package (Word, Excel, Power Point). /li /ulpbr/ppbSoft skills: /b /pulliStrong attention to detail, with the ability to manage multiple priorities effectively. /liliDemonstrated teamwork capabilities, including adaptability to diverse working and communication styles. /liliHigh level of initiative and autonomy in driving tasks forward. /liliFlexibility and responsiveness in dynamic and changing environments. /li /ul