19 ott - Reggio Emilia
Chiesi
Overview In this role you drive the CMC development strategy, IMP supply planning, and budget for GRD projects from candidate nomination to handover to manufacturing for launch. You act as technical lead for CT and ETT workstreams, coordinating internal and external experts to deliver compliant development packages. You partner with cross-functional teams to align with regulatory strategy and long-term business objectives. This role offers impact in rare disease research and collaborations that shape development programs.
Retribuzione / Benefits
annual premio scheme comprehensive benefits package remote work options relocation support private medical insurance wellbeing programme
Responsabilità
Build and own the overall CMC development strategy and long-term plan Drive execution of CMC activities in line with regulatory strategy Coordinate documentation packages for development phases Lead ETT workstreams and assemble required internal/external competencies Manage external consultants and relationships with CMOs/CROs Oversee project budgets for CMC activities Provide SME input for regulatory submissions and quality documentation Mentor team members and disseminate technical knowledge across GRD and adjacent functions
Requisiti fondamentali
Master of Science in relevant field ≥10 years of pharmaceutical industry experience Experience in development/manufacturing of drug substances/products or medical devices Strong leadership and stakeholder management Regulatory interaction experience with EMA/FDA and ICH/GMP knowledge Experience with CMOs/CROs and GMP compliance Excellent written and verbal communication; English fluency Proficiency with MS Office Broad development/manufacturing experience in CGT, biologics and/or small molecules leadership problem-solving clear communication CMC development IMP supply planning regulatory strategy and submissions
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