Natasha has 16 years of experience in Regulatory Operations. She specializes in compiling and submitting US, Canadian, and European submissions in eCTD, and NeeS format. She worked with the following systems: Liquent Insight Publisher, eCTDXpress, Lorenz DocuBridge, eCTD Viewer and Reviewer, Global Submit, Lorenz eValidator, Rosetta eCTD Viewer, First Doc, Tardis, eDOCs, Veeva RIMS Vault, Veeva Registrations Vault, Visio, Microsoft Project, Timelines Pro.
Before joining Hallaran, Natasha worked at Emergent BioSolutions for over nine years as a Sr. Regulatory Operations Specialist responsible for the formatting of documents and the compilation of MAAs, INDs, NDS, and BLA maintenance for the following business units: “Vaccines”, “Therapeutics”, and “Devices” (Combination Products). Natasha collaborated with functional groups for the integration of Veeva RIMS, mapping and migration of documents to the RIMS vault, provided administrative oversight and training on the Regulatory Module in Veeva RIMS; collaborated with Regulatory Affairs Leads, Project Managers, and Schedulers with project resourcing for government proposals. In addition, Natasha collaborated with multidisciplinary functions to streamline internal tools to enhance Regulatory Affairs processes such as SOPs, Work Instructions, and Checklists.
Prior to Emergent BioSolutions, Natasha worked at MacroGenics, MedImmune (now AstraZeneca), and Otsuka Pharmaceuticals.
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Pontificia Universidad Católica de Puerto Rico, Bachelor of Arts, Criminology