Products and processes meet the U.S. FDA, Health Canada, European Medicines Agency (EMA), and ICH (International Council... and EMA regulatory requirements. Demonstrated experience leading CAPA and Change Review Boards, internal audits...
, such as at the FDA;Deep expertise in U.S. regulatory frameworks, with working knowledge of EMA processes preferred;Demonstrated...
preparation for and management of global regulatory inspections (e.g., FDA, EMA, MHRA) Coordinate responses to inspection...
planning and preparation for interactions with the FDA, EMA, and other major health authorities;experience... through major regulatory milestones, including NDA/BLA or equivalent submissions;interactions with FDA, EMA...
, and safer. Responsibilities Support site inspection readiness activities to ensure ongoing compliance with FDA, EMA... environment. Strong knowledge of cGMP and applicable regulatory requirements, including FDA and EMA expectations. Hands...
—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through...
, cleaner, and safer. As part of the Supplier Quality Group, you will help maintain compliance with FDA, EMA, and other cGMP... compliant with FDA, EMA, and other cGMP regulatory requirements, as well as client expectations. Oversee and coordinate...
with appropriate stakeholders. Ensure that all deviation investigations comply with relevant regulatory standards (such as FDA, EMA...
requirements and guidelines (FDA, EMA, PMDA, ICH, etc.), ensuring company compliance and best practices. Partner with cross...
trial agreements and site budgets for industry sponsored studies Solid knowledge of ICH GCP, FDA, EMA and global clinical...