Senior Regulatory Affairs

Sentinel Diagnostics, leader in the Development and Production of Diagnostic Kits for Clinical Chemistry, Immunology, Molecular Biology, Chromatography and Rapid Tests, in order to expand the RA Team, is looking for a:Senior Regulatory Affairs Specialist FDA & International RegistrationsKey Responsibilities:Define and implement regulatory strategies to...

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 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...

Aufgaben und Verantwortlichkeiten As a Senior Regulatory Affairs Expert, you will play a key role in ensuring regulatory compliance and product stewardship across our European operations. Your main responsibilities include: Supporting the development, implementation, and continuous improvement of Regulatory Affairs and Product Stewardship...

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...

Klk Oleo in Lombardy, Milano area seeks a Senior Regulatory Affairs Expert to drive regulatory compliance and product stewardship across Europe. You will support systems, monitor EU regulations, and provide guidance to cross-location teams.The role requires a chemistry/related degree and 5+ years in regulatory affairs, with strong REACH/CLP knowledge and...

Overview In this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products. You will influence product development plans, ensure compliant labeling and support commercial opportunities. You’ll collaborate with GRA, GCD, GCSP and cross-functional teams to maintain global consistency and...

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...

Sentinel Diagnostics Group in Milan seeks a Senior Regulatory Affairs Specialist FDA & International Registrations to lead regulatory strategies for US product registrations. You will prepare FDA submissions and coordinate with regulators and consultants, guiding cross-functional teams to ensure compliance across the product lifecycle. This role requires...