THE FDA COMPLIANCE REGULATORY jobs in SAN DIEGO CA, United Kingdom

Position Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance... with FDA regulations and guidelines in the food and drug-related business. The FDA Compliance & Regulatory Specialist...

required changes. Support regulatory compliance activities, such as audits, CAPAs etc., as needed. Identify ways to improve the... Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include...

Job Description: Job Summary Responsible for regulatory compliance activities associated with commercialized... compliance Develop and/or revise regulatory procedures Support US PMA and Canadian annual reports, Canadian post market...

the company with future regulatory submissions in mind and to ensure compliance. Assists in preparing regulatory... regulations, standards, policies, and guidance that impact the company’s regulatory methods. Ensures compliance with company...

Affairs Specialist to our team. The Senior Regulatory Affairs Specialist leads regulatory compliance objectives for the... regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs...

complex regulatory landscapes, ensuring our groundbreaking products meet all regulatory requirements and reach the market... alignment with applicable guidance. Coordinate and manage Q-submissions for prompt FDA responses. Lead the preparation...

will spearhead regulatory strategies and activities concerning the development and approval of cell therapy products. Reporting... directly to the Chief Medical Officer, the Senior Director will provide strategic leadership, ensuring compliance with global...

neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive...-functionally and with external partners and CRO's. Will Work closely with the Regulatory leadership to prepare regulatory...

products. · Experience in interacting with regulatory agencies, particularly the FDA. · Excellent analytical.... Job Description We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate...

is compliant with the FDA Quality Management System Regulation, ISO 13485, and all applicable international regulatory requirements... industry best practices. Ensure compliance with FDA 21 CFR 820 and ISO 13485 requirements. Train and monitor the team...

with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved.... For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems...

, schedules, and in compliance with regulatory standards. Provides training and qualification to entry level maintenance mechanics...Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the...

, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties...The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California...

are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements... within the pharmaceutical and/or medical device industries. Knowledge of regulatory requirements (cGMP, FDA...

or contain information about investigational compounds or uses not approved by the FDA. I certify that I am a licensed health... approval requirements Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology...

and/or lead local site visits, audits, and inspections from clients, the IACUC, and outside regulatory bodies including... supported the development of 86% of the drugs approved by the FDA in 2021. Equal Employment Opportunity Charles River...

are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements...Job Description: PSC Biotech provides the life sciences with essential services to ensure that health care products...