Regulatory Cmc Senior Specialist

Chiesi Farmaceutici S.P.A. in Parma, IT, seeks an experienced Senior Technical Leader for Analytical Method Development and Validation in GRD CMC. You will lead analytical strategy, development plans, and lifecycle activities for biologics, partnering with CDMOs, CROs, and internal teams. You will guide method development, qualification, validation, and...

Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are...

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,...

Overview As Senior Process Scientist, you will drive the development and manufacturing oversight of LNP-based gene therapy programs within Chiesi Global Rare Diseases. You'll lead formulation development, screening, and process optimization, partnering with external CROs/CDMOs and internal CMC teams to advance candidates from discovery through clinical...