Linda Mota

Director, Global Regulatory Affairs @Takeda

Boston, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2021 — Present

Director, Global Regulatory Affairs @Takeda

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Boston, MA, US

EDUCATION

N/A

Immaculata University

Bachelor's degree, Organization Dynamics

SKILLS

EctdClinical TrialsDrug DevelopmentGcpPharmaceutical IndustrySopFdaRegulatory SubmissionsClinical DevelopmentNda21 Cfr Part 11Regulatory RequirementsIndCapaPharmacovigilanceGmpRegulatory Affairs

ABOUT LINDA MOTA

With over twenty years in biopharmaceuticals, I am an experienced Global Regulatory Affairs professional responsible for formulating and executing comprehensive global regulatory strategies that span all phases of drug development. My role as Global Regulatory Lead encompasses managing global regulatory activities and submission plans to facilitate product registration, engage with health authorities, secure marketing approvals, and oversee life cycle management. My expertise includes navigating regulatory systems in the US, EU, Japan, and other international regions, as well as leading pivotal clinical trials, Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), and worldwide marketing registrations.

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Linda Mota — Director, Global Regulatory Affairs at Takeda in Boston, MA, US | Unifers