Frankfurt, Hesse, Germany
Dynamic leader with broad experience in global regulatory CMC affairs. Fueled by a passion to advance public health goals, my track record includes successful implementation of regulatory strategies and leading regulatory teams. Committed to fostering collaboration and innovation, I am eager to contribute to transformative healthcare solutions that prioritise compliance and efficiency in line with the mission to improve global healthcare outcomes.
Main tasks: • preparation/compilation of Module 3/IMPD for injections/modified release tablets/ inhalation powder/biological medicinal products; • assessment of post-approval changes in respect of CMC documentation, variation classification; • preparation of strategy for post-approval variations (cost/time optimization); • communication with Competent Authorities in view of the registration process (e.g. pre-submission meeting for MRP procedure) or GMP inspections; • designing of the R&D studies for generic tablets/injection/inhalation products; • coordination of R&D projects in cooperation with pharmaceutical companies/subcontractors; for formulations: tablets/ parenterals/inhalation products etc. • management of project teams; • assessment of development studies results; • activities regarding comparability studies for biosimilar product – designing/monitoring experiments, verification of validation/final reports, the study execution within chosen laboratory according to established timeschedule; • planning/designing/analyzing developmental studies according to Quality by Design principles; • designing of the manufacturing process validation (biological medicinal product/active substance/tablets); • preparation/verification of QA documentation (instructions/SOPs); • GMP auditing of analytical laboratories/medicinal product’s manufacturing sites/ API manufacturers (in EU and in third countries); • supporting the manufacturers of the medicinal product during EU GMP inspections; support during CAPA preparation;
Main responsibilities: • designing of R&D studies, assessment of development studies results; • designing of analytical methods validation, preparation of validation protocols/reports/ relevant SOPs; • designing of manufacturing process validation, preparation of validation protocols/reports; • preparation/coordination of analytical methods/technological transfers, preparation of SOPs/protocols/reports; • designing/coordination of comparability studies for biosimilar product; • negotiating quality agreements’ terms and conditions; • preparation/compilation of Module 3 for injections/modified release tablets/ inhalation powder/ biological drugs; • preparation of IMPD for biological medicinal products/tablets;
Regulatory Affairs Specialist in CMC department; Main responsibilities: • assessment of the medicinal product documentation (Module 3) in view for registration possibilities within EU; • preparation/compilation of Module 3/IMPD for tablets/injections; • designing of the development studies for generic tablets;