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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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Oversees regulatory compliance in partnership with the Chief Regulatory Affairs Officer, across all Temple campus', including but not limited to Temple University Hospital, Northeastern Campus, Episcopal Campus, Jeanes Campus and Temple outpatient clinics.
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Provide direct oversight and strategic directionfor the interdepartmental collaboration of staff and services that serve within and in support of perioperative clinical departments; to include: Sterile Processing, Anesthesia Support, and Perioperative Support Services.
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3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
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The Education Coordinator will provide academic management for ITMAT Education, a suite of multiple discrete academic programs including the MS Translational Research, MS Regulatory Science, Master of Regulatory Affairs, ITMAT Certificate in Translational, Regulatory and Entrepreneurial Science, Clinical Trials Fellowship, Research Internships, as well as symposia, workshops and seminars.
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The Field Director, MSL (FD) plans, directs, coordinates and supports the activities of the Medical Science Liaisons (MSLs) within a designated geographic region to achieve scientific and business objectives within a therapeutic area of U.S. Medical Affairs.
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Proclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program. Associate Director of Regulatory Affairs - Permanent - Onsite. Leadership and Management: Provide leadership and management of the Regulatory Affairs functionSupervision and Mentoring Staff.
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Collaborate with Biostatistics [clinical and medical affairs], data science, regulatory, clinical development, medical writing, and other vital functions and represent Statistical programming as the strategic partner to deliver the following but not limited to:A partner who is the advisor for the functional teams and represents the Statistical Programming.
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Collaborates with study team members (including Clinical Operations, Drug Safety, Regulatory Affairs, Precision Medicine, Project Management) to ensure that key milestones are met on time and with high quality.
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They will work within a multi-disciplinary, matrix team ensuring that clinical, scientific, and regulatory issues are appropriately considered with respect to highly complex clinical studies. Collaborates with translational medicine and bioanalytical team to analyze and assess biomarker data.
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Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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The KYDA Partners team is seeking a VP of Compliance & Regulatory Affairs for a growing Biotech group. Serve as principal spokesperson with customers, regulatory agencies, etc. Reporting to the Chief Legal Officer, you will serve as an active member of the executive leadership team, being responsible for compliance with regulatory and legal requirements and strategies that support organizational objectives and operations that are compliant with FDA regulations, state requirements, ISO Standards, AATB Standards, and other applicable regulations.
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Responsible for the planning and direction of regulatory affairs activities. Provide leadership and management of the Regulatory Affairs function. This position is responsible for leading the development, review, and execution of regulatory strategy and operations for drugs and devices throughout the product lifecycle with a focus on early development.
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PRIMARY RESPONSIBILITY Under the supervision of Senior Regulatory Affairs staff, the Manager, Regulatory Affairs is responsible for developing, implementing, and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle.
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Assist Process Engineers and/or Validation Scientists in coordinating cleaning, process validation and technical / process operations activities with company quality units, operation, R&D and regulatory affairs for commercial or R&D products.
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regulatory affairs jobs in Philadelphia, PA
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