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Clinical Regulatory Specialist Jobs in Union, 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
Regulatory Relations Specialist Jobs
By Compunnel Inc. At New York City Metropolitan Area, United States
Our client is a leading independent management consulting firm focused on the global financial services industry.
They are looking for a
P.S - This is a hybrid opportunity based out at Midtown, NY.
Regulatory Specialist Jobs
By Barentz At North Kingstown, RI, United States
Work in close collaboration with our corporate regulatory, commercial, operations, and purchasing teams to comply with OSHA requirements
Assist in the implementation and continuous improvement of Responsible Distribution certification, including training, internal audits, and certification audits.
Other duties and responsibilities as requested
Previous experience (3+ years) in a regulatory/compliance role considered a plus
Strong problem solving, organizational skills, attention to detail, and communication skills
Strong interpersonal skills and ability to communicate effectively throughout the organization
Global Regulatory Specialist Jobs
By eBay At Draper, UT, United States
2-5 Years Proven Project Management Experience.2-5 years experience with a federal government agency is preferred.
Effective and confirmed negotiation skills and have the ability to influence decisions and others.
Handle and support critical issues from regulators and monitoring authorities, media, and non-government organizations from around the world.
Support managing and further developing the eBay Regulatory Portal.
Be proficient with eBay’s customer service tools.
Conduct investigations and analysis of non-compliant/potentially criminal conduct.
Clinical Specialist Jobs
By ImpactBio At Los Angeles Metropolitan Area, United States
Outstanding customer-focused and account management skills.
Become an expert at understanding the Healthcare Partner’s unmet needs related to the management and protection of closed surgical incisions.
Effectively communicate the clinical, ease-of-use and cost-savings benefits of NPseal® compared to traditional dressings and NPWT competitive offerings.
Develop and manage relationships with Key Customer decision-makers including Physicians, Nurses, decision makers, and Operating Room staff.
Manage travel and expenses per approved budget and timelines.
Other responsibilities as necessary to perform position.
Regulatory Policy Specialist Jobs
By Savan Group At Vienna, VA, United States
Interest in data and information management.
Bachelor’s degree with 3 years of relevant experience.
Strong written and oral communication skills
Experience with information security programs (e.g., Controlled Unclassified Information, Privacy, etc.)
Experience independently developing technical documents and research papers.
Experience developing and delivering presentations for senior leadership.
Product & Regulatory Specialist Jobs
By 80Twenty At Alhambra, CA, United States
Crisis Management: Assist in handling product-related crises or recalls, coordinating efforts to address safety concerns and regulatory issues promptly.
Bachelor's degree in a relevant field, such as Regulatory Affairs, Product Management, or a related discipline.
Product Documentation: Manage and organize product documentation, including specifications, testing reports, and certificates, to support compliance efforts.
Labeling and Packaging: Review and approve product labeling, packaging materials, and marketing materials to ensure they adhere to regulatory requirements.
Knowledge of relevant regulations and standards in the industry, with a strong focus on product safety and compliance.
Strong attention to detail and organizational skills.
Regulatory Coordinator Iii/Clinical Researcher
By Cedars-Sinai At West Hollywood, CA, United States
Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical research/clinical trials.
May provide training and education to other personnel.
Participates in required training and education programs.
Five (5) years minimum of directly related experience; 2 years of regulatory experience and 3 years of clinical research experience.
Ability to identify areas of project interest and connect with appropriate support group: CCTO SPIN, IRB, Tech Transfer
Regulatory Specialist - Prior Notice
By Registrar Corp At Hampton, VA, United States
Perform administrative and data entry job functions, including analyzing and interpreting Microsoft Excel data and database management.
At least 2 years of experience working in a customer service, administrative assistant, or data entry-driven role
Spanish foreign language skills required
Strong problem-solving and critical thinking skills.
Solid organizational skills with the capability to support multiple simultaneous projects.
Strong technical (system) and computer skills with proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint, etc.).
Research Regulatory Specialist Jobs
By Insight Global At New York, NY, United States
-Exceptional communication, analytical, presentation and time management skills
-Excellent working knowledge of regulatory compliance requirements and procedures
-Ability to demonstrate impact on project goals through proactive solutions and keeps management aware of project schedules/timelines.
-Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications
-Extensive knowledge of oncology clinical trials and oncology terminology required.
Regulatory Operations Specialist Jobs
By CymaBay Therapeutics At Newark, CA, United States
Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates
Manage the regulatory activities log tracking annual and current submissions
Direct publishing experience a plus
Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.
Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs
Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills