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Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development,...
system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Manager, RegulatoryAffairs role is responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing...
Overview The Senior Manager, RegulatoryAffairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Maintain current awareness of evolving FDAregulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Company Overview: Dyne Therapeutics is focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging...
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
This is a fully remote position. This person should be a subject matter expert on Regulatory Affairs as it relates to HealthCanada. Provides regulatory input to facilitate the timely preparation...
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Manager of Regulatory Affairs Online Courses and Training Opportunities
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OverviewDrug Regulatory Affairs (DRA) is a field that involves the study and implementation of regulations, guidelines, and laws related to the development, production, and marketing of...
This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC...
Regulatory Affairs & Medical Writing course provides a possibility to learn strategies, tricks, action plans to become confident in collaboration within a clinical and regulatory environment to...
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