Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Apr 29 2025 Job Purpose Ensure the development of appropriate...
Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, RegulatoryAffairs....
Maintain current awareness of evolving FDAregulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory...
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
management and regulatory strategy within WHOOP Support development and maintenance of WHOOPs FDA-compliant QMS, ensuring adherence to 21CFR820 and ISO13485:2016 Coordinate and lead internalaudits...
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...
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...
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and...
Director of Regulatory Affairs Operations, Ultrasound** The Director of Regulatory Affairs Operations for the Ultrasound business will be responsible for leading a global Regulatory Affairs team...
system and regulatory product compliance requirements; e.g 21CFR820, ISO13485/9001, QMSR, EU MDR, ISO 14971, UL, CSA, NSF, NMPA, Health Canada We provide competitive salary, an annual incentive...
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Manager of Regulatory Affairs Online Courses and Training Opportunities
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Navigate Global Regulations with Confidence: Regulatory Affairs CertificationRegulatory compliance is critical for industries like pharmaceuticals, medical devices, biotechnology, and food,...
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...
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