Teams at QbD Group

Provide CMC regulatory consulting for medicinal products across development, registration, and lifecycle management. Prepare and review submission documentation, support Health Authority responses, assess drug substance and drug product development, review GMP and manufacturing documentation, verify batch records, and coordinate client projects within scope, budget, timelines, and regulatory requirements.

Lead European regulatory submissions, renewals, variations, lifecycle management, and regulatory strategy for medicinal products. Coordinate eCTD publishing, electronic submissions, product information maintenance, health authority interactions, and responses to regulatory queries. Assess regulatory impacts of business and manufacturing changes, ensure compliance with EU pharmaceutical requirements, manage multiple priorities, and mentor junior team members.

Provide hands-on GMP quality assurance support across pharma/biotech/MedTech projects: batch review and release, deviations/CAPAs, change controls, sterile manufacturing exposure, audit/inspection support, and stakeholder communication while progressing toward QP responsibilities.