Christy Wood

Associate Director, Regulatory Strategy @Jazz Pharmaceuticals

Santa Fe County, NM, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2020 — Present

Associate Director, Regulatory Strategy @Jazz Pharmaceuticals

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Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development • Lead regulatory interactions with health authorities, marketing partners, and vendors (as necessary) • Participate and support on a multi-disciplinary team to establish Regulatory Strategies for commercial products, late and early stage development programs. • Ensure the timely submission and accuracy of INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents. • Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met. • Support EU, US and global clinical trials and commercial license maintenance.

SKILLS

Regulatory SubmissionsClinical TrialsValidationSoftware DocumentationRegulatory AffairsGcpFdaSopLifesciencesGmpLife SciencesPharmaceutical Industry21 Cfr Part 11BiotechnologyGlpCapaChange ControlGxp

ABOUT CHRISTY WOOD

Over 18 years of experience in the pharmaceuticals industry. Having held various…

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Christy Wood — Associate Director, Regulatory Strategy at Jazz Pharmaceuticals in Santa Fe County, NM, US | Unifers