manages Regulatory Affairs Associates and Specialists. Provides regulatory advice on strategy and manage projects in the provision of regulatory affairs...
Park Area
As SR Regulatory Affairs Specialist, you... for FDA regulated and other clinical studies, assuring that all regulatory submissions and documentation...
in developing clinical study designs, clinical protocols, clinical data analysis, and preparing clinical... clinical study designs, clinical protocols, clinical...
for regulatory documents, and submissions; represent the company with domestic regulatory authorities, contractors and corporate partners; provide regulatory...
to the Regulatory Affairs and Clinical Operations VP... and shipment of clinical regulatory requirements to clinical sites. Reviews regulatory documentation...
of the regulatory affairs staff. Develops regulatory... of the regulatory affairs team... Develops strategy and budgets for the regulatory affairs component of...
regulatory submissions.
Provide support to clinical... 2 years in pharmaceutical regulatory affairs.
Regulatory Affairs Certification Exam (RAC) certification...
Regulatory-related topics, guidelines, and regulatory... Quality Assurance & Regulatory Affairs-related activities, as well as strong knowledge of other clinical...
Affairs experience is strongly preferred; clinical... objectives and proposed clinical studies have been captured within the Clinical Development Plan (CDP...
of Scientific and Clinical affairs * * Overview of... and Clinical Affairs to the growing, dynamic team * Job Description:The VP Clinical Affairs directs and...
within GSK PV and Global Regulatory Affairs
• Understanding of PV and global regulatory requirements;... regulatory inspections of PV and Regulatory Affairs...
local
regulatory and accrediting agencies for
these programs. This position will report tothe Director of Regulatory
Affairs at the Duke Translational
Medicine...
Clinical Feasibility Specialist I & II and Clinical... clinical research within a CRO including appropriate expertise in feasibility assessments and/or clinical...
scientific and clinical research staffing company in the
world. We employ more than 700 clinical research... Liaises with Global Regulatory Affairs, therapeutic...
for the ethical and regulatory oversight of all... research, research administration and/or regulatory affairs is highly desirable. Previous IRB experience...
Education, and Clinical Center; the Center for Health Services Research in Primary Care; the VISN 6 Mental Illness Research, Education, and Clinical Center, and...