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Clinical Regulatory Affairs Specialist Jobs in New York

Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global At New York, NY, United States
-knowledge and experience in the insurance sector
-prior experience as an insurance supervisor
-prior experience as an actuary, insurance contract lawyer, or consultant in the financial services
-prior experience in coordinating projects involving a wide array of stakeholders.
-prior experience on ESG or cyber matters.
-ability to navigate and understand prudential regulation and supervisory guidance applicable to the insurance sector
Regulatory Affairs Specialist Jobs
By CitiStaffing At New York, NY, United States
Significant experience analyzing securities trading
Excellent computer/technology skills, particularly using systems to retrieve order and trade data and Microsoft Excel
Experience using Relativity and/or Global Relay Retrieval Platforms
Interface with regulators, including negotiating request limitations and response deadlines
Review and prepare documents for production to regulators and ensure timely and accurate responses to all regulatory inquiries
Analysis of requests, responses, and related documents for potential regulatory issues
Regulatory Affairs Specialist Jobs
By TMRW Life Sciences, Inc. At , New York, 10013, Ny $100,000 - $150,000 a year
Manages and maintains Regulatory registrations including FURLS, EUDAMED, UDI database and other country specific registration databases,
Reviews promotional material and labeling for compliance with regulatory requirements.
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Bachelor’s degree or equivalent work experience
3+ years related work experience in regulatory affairs required
FDA Class I and II medical device experience required

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