Natasha Garcia

Natasha Garcia LEAD CONSULTANT, REGULATORY OPERATIONS

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 to integrate Veeva RIMS, mapped and migrated documents to the RIMS vault, provided administrative oversight and training on the Regulatory Module in Veeva RIMS, and collaborated with Regulatory Affairs Leads, Project Managers, and Schedulers on project resourcing for government proposals. In addition, Natasha collaborated with multidisciplinary teams to streamline internal tools and enhance Regulatory Affairs processes, including SOPs, Work Instructions, and Checklists. 

Prior to Emergent BioSolutions, Natasha worked at MacroGenics, MedImmune (now AstraZeneca), and Otsuka Pharmaceuticals. 

Natasha holds a BA in Criminology from Pontificia Universidad Católica de Puerto Rico.