Clinical Regulatory Affairs Specialist Jobs
Senior Specialist, Regulatory Affairs
By H&H Group
At Orlando, FL, United States
International Regulatory Affairs Specialist
By Scholl's Wellness Company
At Parsippany, NJ, United States
Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc.
At Austin, TX, United States
Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global
At New York, NY, United States
Quality And Regulatory Affairs Analyst - Genetics Clinical Trials
By Mount Sinai Health System
At United States
Regulatory Coordinator Iii/Clinical Researcher
By Cedars-Sinai
At West Hollywood, CA, United States
Specialist I, Regulatory Affairs - Medical Device
By Werfen
At , San Diego, 92121
$75,000 - $85,000 a year
Regulatory Affairs Intelligence Specialist
By Abbott Laboratories
At , Plymouth
$56,700 - $113,300 a year
Global Clinical & Regulatory Affairs Operations Coordinator
By Orion
At ,
$28 an hour
Regulatory Affairs Specialist Cmc
By Viatris
At United States
Senior Regulatory Affairs Specialist
By NuVasive, Inc.
At , San Diego
$96,000 - $160,000 a year
Regulatory Affairs Specialist Jobs
By ICON
At , Farmingdale, 11735
Sr. Regulatory Affairs Specialist
By Abbott Laboratories
At , Des Plaines
$71,300 - $142,700 a year
Regulatory Affairs Specialist Jobs
By Philips
At , Cambridge
Specialist, Regulatory Affairs Jobs
By Edwards Lifesciences
At ,
Regulatory Affairs Specialist Cmc
By Viatris
At , Remote
$41,000 - $93,000 a year
Regulatory Affairs Specialist Jobs
By Verathon
At , Bothell
$89,500 - $138,600 a year
Regulatory Affairs Specialist Jobs
By Medtronic
At , Woburn
Regulatory Affairs Specialist Jobs
By AM Logic Corporation
At , Edison, 08820, Nj
Regulatory Affairs Specialist Ii
By Thermo Fisher Scientific
At , Fremont, 94555, Ca
Are you looking for an exciting opportunity to join a dynamic team in the Clinical Regulatory Affairs field? We are looking for a Clinical Regulatory Affairs Specialist to join our team and help us ensure compliance with all applicable regulations. You will be responsible for preparing and submitting regulatory documents, tracking submissions, and providing regulatory support to internal and external stakeholders. If you are a detail-oriented professional with excellent communication and organizational skills, we want to hear from you!
Overview Clinical Regulatory Affairs Specialists are responsible for ensuring that clinical trials and other research activities comply with applicable regulations and standards. They work closely with clinical research teams to ensure that all regulatory requirements are met and that the research is conducted in an ethical and safe manner. Detailed Job Description Clinical Regulatory Affairs Specialists are responsible for ensuring that clinical trials and other research activities comply with applicable regulations and standards. They work closely with clinical research teams to ensure that all regulatory requirements are met and that the research is conducted in an ethical and safe manner. Clinical Regulatory Affairs Specialists are responsible for developing and maintaining regulatory strategies, preparing regulatory submissions, and providing regulatory guidance to clinical research teams. They also review and approve clinical trial protocols, analyze data from clinical trials, and provide regulatory advice to sponsors and investigators. Job Skills Required• Knowledge of applicable regulations and standards
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and problem-solving skills
• Ability to manage multiple tasks and prioritize work
• Proficiency in Microsoft Office applications
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research or regulatory affairs
• Knowledge of applicable regulations and standards
• Understanding of clinical trial design and data analysis
• Ability to interpret and analyze clinical trial data
Job Knowledge
• Knowledge of applicable regulations and standards
• Understanding of clinical trial design and data analysis
• Knowledge of clinical research processes and procedures
• Knowledge of medical terminology
• Knowledge of Good Clinical Practice (GCP)
Job Experience
• At least two years of experience in clinical research or regulatory affairs
• Experience in preparing regulatory submissions
• Experience in reviewing and approving clinical trial protocols
• Experience in analyzing clinical trial data
Job Responsibilities
• Develop and maintain regulatory strategies
• Prepare regulatory submissions
• Provide regulatory guidance to clinical research teams
• Review and approve clinical trial protocols
• Analyze data from clinical trials
• Provide regulatory advice to sponsors and investigators
• Monitor clinical trials for compliance with applicable regulations and standards
• Ensure that research is conducted in an ethical and safe manner
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