Global Regulatory CMC Technical Lead

ClinChoice is seeking a Regulatory CMC Technical Lead Consultant in Italy to drive regulatory CMC submissions and lifecycle management for global products. You will author and review CTD M2/M3 sections, coordinate with core teams, and ensure alignment with global regulatory expectations.You will collaborate cross-functionally with development teams, CMOs,...

Regulatory CMC Technical Lead Consultant Job Description: Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities. Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team, with full responsibility and no need of supervision. Act...

Regulatory CMC Technical Lead Consultant Italy Regulatory CMC Technical Lead Consultant Job Description: Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities. Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team, with full...

Regulatory CMC Technical Lead Consultant Italy Regulatory CMC Technical Lead Consultant Job Description: Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities. Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team, with full...

PQE Group è alla ricerca di un Regulatory Affairs CMC Expert Consultant per guidare sottomissioni regolatorie a livello globale, con focus su Small Molecules e IND/IMPD, MAA, NDA, ANDA. Richiesta autonomia e gestione simultanea di progetti CMC, con padronanza di linee guida ICH/EMA/FDA e inglese eccellente.La posizione prevede contratto a tempo...

PQE Group è alla ricerca di un Regulatory Affairs CMC Expert Consultant per guidare sottomissioni regolatorie a livello globale, con focus su Small Molecules e IND/IMPD, MAA, NDA, ANDA. Richiesta autonomia e gestione simultanea di progetti CMC, con padronanza di linee guida ICH/EMA/FDA e inglese eccellente.La posizione prevede contratto a tempo...

PQE Group è alla ricerca di un Regulatory Affairs CMC Expert Consultant per guidare sottomissioni regolatorie a livello globale, con focus su Small Molecules e IND/IMPD, MAA, NDA, ANDA. Richiesta autonomia e gestione simultanea di progetti CMC, con padronanza di linee guida ICH/EMA/FDA e inglese eccellente.La posizione prevede contratto a tempo...

Sei pronto ad entrare in una realtà internazionale che sta ridefinendo gli standard dell’industria farmaceutica e dei Medical Device? In PQE Group, la nostra divisione di Regulatory Affairs è sempre in una fase di grande crescita grazie ad un mercato in continua evoluzione che sempre più richiede la qualità dei nostri servizi. Per questo motivo abbiamo...

Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions,...