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The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. Support Global Regulatory
This individual actively leverages audit / inspection outcomes / trends to affect improvement in clinical trial quality and compliance with Ionis and global regulatory requirements. This role also has responsibility for preparation, management, and follow-up of global Health Authority (HA) GCP inspe
The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. Support Global Regulatory
Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. The ideal candidate will have over 10 years of experience in the Medical Device industry and at least 5 years in Regulatory Affairs. This role involves deve
Artiva is seeking an Associate Director, Clinical Quality Assurance to serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development. Define, support and deliver GCP training for Clinical Operations staff, contributing to the bro
Artiva is seeking an Associate Director, Clinical Quality Assurance to serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development. Thorough knowledge of current Good Clinical Practices and Good Clinical Laboratory Practices as
Support and deliver GCP training for Clinical Operations staff, contributing to the broader clinical quality training program. Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development to ensure compliance with ICH-GCP, appli
The Associate Director, Quality Operations plays a critical role in ensuring the quality, compliance, and integrity of Acadia's clinical and commercial products. It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to consider
TRANSITIONAL CARE UNIT: * Follows all newly admitted patients through their first 4 weeks of dialysis and coordinating their transitional dialysis care * Reinforces all education and care related matters as it relates to the new patient as allowed by state law * Liaisons with appropriate FKC st
The Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end-to-end submission execution. Minimum of 12 years of progressively responsible experience in
To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor's degree in life sciences, engineering, or a related field, along with at least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs. Regulatory Affair
As a Clinical Manager with Fresenius Medical Care, you will ensure that quality patient care is delivered while maintaining clinical operations. Collaborates with the Medical Director and the Clinical Manager/Charge Nurse regarding the provision of quality patient care in the dialysis facility incor
The Medical Director will work in close partnership with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, Safety/Pharmacovigilance, Translational Medicine, and Medical Affairs. This role provides medical leadership across one or more clinical development progr
In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams. Prep
Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs. The Company is in search of a Vice President for Regulatory Affairs, Clinical Operations, and Medical Affairs. A minimum of 10 years' in regulatory affairs leadership is required, along with significant experience in overseei
This role oversees the development, review, and maintenance of product labeling and provides regulatory guidance throughout the Medical, Legal, and Regulatory (MLR) review process. It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without
Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC. Project Manager, Regulatory Affairs (Clinical and CMC). This remote contract role involves leading cross-functional regulatory activities, enhancing project management standards, and mentoring junior project mana
The Manager, Medical Writing Operations is responsible for leading document specialist support across the Medical Writing function and for authoring and coordinating regulatory, clinical, and safety documents. Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pha