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Clinical Regulatory Specialist Jobs in Arkansas

100% Remote- Regulatory Specialist ($27.00 - $30.00 / Hour)
By Talentify.io At United States
Manage a steady stream of projects, including the preparation and development of approved packaging production artwork.
Follow defined processes and documentation to ensure the highest quality and compliance to cGMP and FDA requirements.
Bachelor's degree in Graphic Design, Packaging, New Media, Printing, or equivalent experience.
In-depth knowledge of Adobe Illustrator and InDesign.
Understanding of GMP requirements in a regulated environment is a plus.
Oversee the artwork approval process, collaborating with Regulatory, Marketing, Legal, Engineering, Quality, and Supply Chain teams.
Regulatory Operations Specialist Jobs
By LeadStack Inc. At United States
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Arranges event planning for internal meetings and Kaizen events, including ordering supplies, coordinating meals, arranging hotel room blocks, etc.
Maintains organizational charts for both departments and maintain email distribution lists.
Supports expense reporting for leadership in GRA and GCA.
Title: Global Clinical & Regulatory Affairs Operations Coordinator
8:00 AM - 5:00 PM EST (includes one hour lunch)
Remote Regulatory Specialist ($28.00 - $31.25 / Hour)
By Talentify.io At United States
Bachelor's Degree and 3-5 years of relevant experience or equivalent combination of education and experience.
Knowledge and experience with FDA Clinical Trial regulations and guidance.
3 years of relevant experience in an academic regulatory environment.
Experience with IND/IDE/Clinical Trial Application.
Process initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Board (IRB).
Prepare and process regulatory documentation through IRB, CTSRMC, FDA, and other regulatory review committees.
Senior Regulatory Specialist Jobs
By Storm4 At United States
3+ years of experience working in agricultural biotechnology and/or phytosanitary regulatory or similar
BS in biology, crop science, plant pathology, agricultural business, or related field, graduate degree preferred, or equivalent experience
Knowledge of APHIS administrative procedures and regulations
Experience interacting with state, federal, or international regulators (preferred)
Comprehensive Benefits Plan, including Medical, Dental, Vision, HSA/FSA, 401k, Life Insurance, Short-Term & Long-Term Disability, and more!
🌎 Location: U.S Remote (Some Travel)
Regulatory Specialist Jobs
By Eliassen Group At United States

Years of regulatory specialist experience in a clinical trial environment (ie premarket)

One or more of the Regulatory Certifications- AAAHRP, SOCRA, PRIM&R and similar organizations. GCP training and/or certification

Regulatory Program Specialist (Remote)
By OCHIN, Inc. At United States
Maintains a body of knowledge regarding all health care and health IT laws and regulations, including but not limited to:
Skilled Nursing Facilities Payment System
Reviews, revises, and/or drafts policies and procedures to meet regulatory requirements
Two years’ experience working in a healthcare regulatory affairs department.
Certification in Healthcare Compliance (CHC) preferred, or ability to obtain certification within two years.
Applicable healthcare industry experience such as experience with hospitals, FQHC’s, and governmental healthcare regulations are desired.
Clinical Research Associate (Study/Ctms/Regulatory)
By Rangam At United States
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Required Skill 5: Experience with using clinical trial management systems
What years of experience, education, and/or certification is required?
Required Skill 1: Clinical Research Experience – could be in various roles (study coordinator, regulatory, compliance, safety, etc.)
What are the top 5 skills/requirements this person is required have?
Required Skill 3: Good communication
Clinical Research Regulatory Coordinator
By Medix™ At United States
Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.
Experience creating Informed Consent Documents that comply with HRPP/ IRB policies and procedures, FDA regulations, and sponsor requirements.
Experience with editing, including summarizing information into concise and condense documents.
Knowledge of oncology and hematology.
Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Working knowledge of Human Research Protections Program (HRPP/IRB) policies and Procedures.
Regulatory & Clinical Affairs Specialist
By Compass Life Sciences At United States
Coordinating with administrative and research assistants and managers to coordinate
Experience authoring, assembling, and submitting IND applications
2+ years of experience in regulatory or clinical affairs.
Writing experience is required; examples to demonstrate successful writing preferred.
Ability to research, write and manipulate data through knowledgeable use of online technologies.
Author, assemble, and submit IND applications to FDA.
Regulatory Specialist - Remote Opportunity
By BevSource At United States
Working knowledge of industry and regulatory requirements
Act as lead project manager for Regulatory projects
5-7 years’ minimum experience in FDA, USDA, and/or TTB Compliance
Knowledge of beverage industry terms and processes
Attention to detail and organizational skills
Strong critical thinking and problem-solving skills