CMC Regulatory Lead – Biologics

Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines, with remote options across Europe. You will collaborate with manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance across variations, renewals, and market expansions.The role...

Parexel is seeking a Senior Regulatory Affairs Associate to lead post-approval CMC activities for biologics and vaccines. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance.This role offers remote options in several European locations and focuses on variations, renewals, and...

Parexel is seeking a Senior Regulatory Affairs Associate focused on CMC for biologics and vaccines. The role involves post-approval regulatory activities, worldwide submissions, and close collaboration with manufacturing, QA, QC, and regulatory teams to drive submission strategies and risk mitigation.This position supports variations, renewals, and market...

Parexel is seeking a Senior Regulatory Affairs Associate to 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.Responsibilities include developing post-approval CMC submission...

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, delivering...

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced senior CMC leader for protein biologics drug substance development within GRD CMC. You will lead upstream/downstream development, analytical control strategies, comparability, and lifecycle management for recombinant protein therapeutics. The role requires deep CMC expertise, leadership of...

Chiesi Farmaceutici S.p.A. is seeking a GRD Technical Leader to manage budget, strategy, and execution for CMC development and IMP supply. The role directs ETT workstreams, collaborates with CT and product teams, and leads external partners to drive development milestones and regulatory approvals. The candidate will lead technical reviews, ensure...

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...

Select how often (in days) to receive an alert: 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....