In alignment with PTC’s global regulatory strategies, leads the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development.
Serves as a liaison to regional regulatory Health Authorities including the European Medicines Agency (EMA), the UK MHRA and other national authorities and provides guidance and advice on regulatory and policy developments within the region to PTC’s global regulatory team and other key stakeholders. Actively maintains knowledge of regional regulatory requirements (e.g. new regulations, laws, etc.).
Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to: Clinical Trial Applications (CTAs); Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals) and customized dossiers for the registration of drug products in countries within the region.
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