- HCA Healthcare (Thousand Oaks, CA)
- …Healthcare colleagues invested over 156,000 hours volunteering in our communities. As a Clinical Quality Specialist with Los Robles Regional Medical Center you ... in our organization. We are looking for an enthusiastic Clinical Quality Specialist to help us reach...clinical performance, process improvement and Continual survey readiness compliance . + You will function as a role model… more
- Cedars-Sinai (Beverly Hills, CA)
- …Responsibilities:** + Prepares and submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices. + Advises ... to be a part of breakthrough research?** The Lead Regulatory Coordinator prepares and submits large and/or complex protocols...Entity** : Cedars-Sinai Medical Care Foundation **Job Category** : Compliance / Quality **Job Specialty** : Research… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require ... **Description** The Clinical Development and Medical Affairs Fellow is a...regulatory activities required of an NDA Holder for compliance to FDA requirements for US products in BIPI's… more
- Abbott (Santa Clara, CA)
- … requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory ... have targeted mitigations to align with FDA expectations, ensuring high- quality submissions and predictability for approval + Assists BU... and related teams. + Evaluate risk of and regulatory solutions to product and clinical safety… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … regulatory affairs related to the development of novel therapeutics including quality , preclinical and clinical areas of drug development and the ... policies/procedures required to ensure compliance with regulations. **In this role, a typical day...Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical… more
- Lilly (Indianapolis, IN)
- …byleveragingteam expertise, as well as scientific, drug/device clinical development and knowledgefromhealth authorities such as ... to regulatory issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems. + Own… more
- Sanofi Group (Morristown, NJ)
- …timelines for clinical trial initiation. + Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission ... **Main Responsibilities** : + Enables the GRL by providing quality regulatory input and position to internal...internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects.… more
- Hologic (Louisville, CO)
- … regulatory requirements. + Recommend updates to labeling, manufacturing, marketing, and clinical protocols for regulatory compliance . + Collaborate with ... cross-functional teams-including R&D, Clinical , Quality , and Marketing-participating in design reviews and developing regulatory strategies for product… more
- Envista Holdings Corporation (Brea, CA)
- …by relevant authorities, assess their impact on the organization, and provide timely regulatory guidance and support to ensure compliance . + Develop and maintain ... review and evaluation of product, manufacturing, and labeling changes to determine regulatory reporting requirements and ensure ongoing compliance . + Follow… more
- Takeda Pharmaceuticals (Boston, MA)
- … nuances and requirements. + Basic knowledge of scientific principles and regulatory / quality systems relevant to drug development. + Ability to co-author, ... life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more