Dr. Marco Schmitz

Serving as senior contact for regulatory issues including effectively liaising with clients and local partners, project managers and internal staff as well as with regulatory authorities. Managing, coordinating, supporting and mentoring assigned regulatory team, and providing ongoing regulatory advice and guidance to ensure regulatory concerns are planned and accounted for. providing format and contents of product information texts and labelling, reviewing and approving artworks and promotional materials

Preparing and submitting marketing authorization applications in EU for assigned projects, repeat-use procedures and MAH transfers. Maintaining marketing authorizations by reviewing, preparing and submitting variation applications, renewals, PSURs, article 61(3) notifications. PhVig. related activities for the company (maintaining product dictionary (XEVMPD), detecting and submitting safety variations). Handling national phases, coordinating artwork preparation. Pricing & reimbursement applications in ES.

Out-licensing, regulatory services to clients, B2B with Polpharma. Preparing and submitting registration documentation (module 1-3, compiling modules 4-5) for MR/DCPs and national procedures (EU and worldwide). Evaluating and tracking of changes, preparing and submitting of variations and renewals in EU, adapting the same for customers outside of Europe according to local requirements, updates of product information. Expert advice regarding regulatory strategy and data requirements.

Lifecycle management with main focus on CMC. Assurance and maintenance of marketing authorizations (planning, evaluation and tracking of changes (change control) and preparation of variation packages). Support of new submissions and renewals; assessment and verification of quality part of the dossier Responding deficiency letters, ensuring regulatory compliance, preparing expert reports. Assessment of API suppliers (ASMFs/CEPs), coordination of site transfers (in- and outsourcing).

Organokatalyse, Metallorganik, Synthesechemie