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Clinical Regulatory Specialist Jobs

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 Specialist Jobs
By BCforward At New York, NY, United States
5+ years minimum relevant experience
Prior experience in regulatory driven remediation e.g., MRA, Consent Order etc. and advantage.
Experienced in working with stakeholders
BCforward is currently seeking highly motivated Regulatory Control Lead @New York/Jersey City, NJ or Tampa.
We place consultants for end clients all over USA.
Location: New York/Jersey City, NJ or Tampa
Regulatory Specialist Jobs
By Mindlance At California, United States
EDUCATION AND EXPERIENCE YOU’LL BRING
Previous experience working in a highly matrixed and geographically diverse business environment
Proficient with MS Office suite (Word, Excel, Outlook)
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Regulatory/Qa Specialist Jobs
By Key Corporate Services, LLC At Florida, United States
Our client offers a competitive salary along with full benefits and 401K match
2+ years of experience in the Pharma/Biotech space
2+ years of experience in a Quality or Regulatory position
Role reports directly to the VP of Lab Operations who fosters an environment of learning and growth for their team
Join a stable company that has been in business for over 30 years
BS or higher in a relevant scientific field
Regulatory Specialist Jobs
By Top Quality Recruitment (TQR) At Cape Coral, FL, United States
Complete all other duties as assigned by management.
Strong interpersonal and communications skills and organizational and planning abilities needed to handle multiple tasks concurrently.
Research of International, Federal, State, local, and internal regulatory requirements
Maintain working knowledge and understanding of existing and emerging food and dietary supplement regulations.
Assisting with obtaining, and/or renewing relevant national certifications.
Work closely with the Quality Manager and Product Development teams to ensure compliance.
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.
Regulatory Specialist Jobs
By Indenovo Global Search & Selection At New York City Metropolitan Area, United States
Detail-oriented with exceptional organizational and time management skills.
5 years of regulatory affairs experience in the [industry] sector.
Knowledge of current US & Global regulations pertaining to flavor & fragrance industries
Knowledge of WERCS, Oracle, AS/400
Proven ability to interpret and implement regulatory requirements.
Excellent communication, analytical, and problem-solving skills.
Senior Regulatory Specialist Jobs
By Stanford University At , Stanford, Ca $77,000 - $134,000 a year
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting.
Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.
Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.
Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.
Clinical Accreditation And Regulatory Specialist Rn - Regional Office
By Kaiser Permanente At , Rockville, Md $115,500 - $149,380 a year
Minimum eight (8) years of experience in a healthcare setting required.
Interpreted and applied accreditation standards, CMS regulations, and other regulatory requirements in health care settings.
Experience as a leader or coordinator during at least three major accreditation surveys, equivalent state, or other regulatory agency surveys.
Eight (8) years of experience with survey readiness preferred.
Healthcare accreditation certification or quality certification (CPHQ) preferred.
Previous quality improvement experience or compliance preferred.
Regulatory Specialist Jobs
By ARServices At Fort Belvoir, VA, United States
Detail-oriented, self-starter with excellent communication and time management skills.
Liaison for DTRA STMs and PMs, project team and line management, with USAMRDC Office of Human and Animal Research Oversight (OHARO)
Experience meeting regulatory requirements for early research involving human and animal subjects
Knowledge of the DoD acquisition policies, preferably with experience in the Joint CBDP
Minimum of two years’ experience with a BS, or 1 year with a MS.
Experience with the DoD Joint Chemical Biological Defense Program (CBDP)
Junior Regulatory Specialist Jobs
By Worley At , Houston, Tx
Track record of successful management of projects / work packages to meet agreed budget and schedule
Requires knowledge of reciprocal effects of work upon other fields.
3+ years of professional experience, preferably with an environmental consulting organization, an operator, contractor or regulator
Excellent client and agency interfacing skills
Competitive and comprehensive compensation, benefits package
Opportunities to integrate into engineering and project delivery to deliver meaningful benefits to the environment and communities
Regulatory/Clinical Affairs Specialist
By GSI At Sandy Springs, GA, United States
Maintain knowledge of current regulatory requirements and standards, and communicate changes to relevant stakeholders.
Knowledge of FDA regulations and international regulatory requirements
Offering a highly competitive salary, comprehensive benefits package, and opportunities for growth and advancement within the company.
4 + years of experience in regulatory affairs within the medical device industry.
Experience with registration and commercialization of medical devices
Strong analytical, problem-solving, and decision-making skills.
Regulatory Operations Specialist Jobs
By Jobot At San Diego, CA, United States
Incredible company culture and proven management team
MS WORD knowledge with WORD styles to format various documents for regulatory submissions
ECTD publishing experience with using eCTD software to produce a compliant electronic submission
3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)
QC experience is a plus
REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech
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
Regulatory Specialist Jobs
By nutpods At Bellevue, WA, United States
Base salary range of $65,000 to $85,000 per year, depending on education, experience, knowledge, skills, and abilities
Maintain accurate, operational, and functional quality databases related to product specifications and regulatory Information, including label management
Support packaging quality control and management
Manage 3rd party certifications for products
Manage relevant QA programs as assigned
Manage document and version control for operations related documents and programs
Regulatory Specialist, Fragrance & Beauty
By CHANEL At Piscataway, NJ, United States
Section 5: What skills you will learn? What experiences might you have?
Trained and acting in-person coverage for quality assurance (QA) personnel, as well as helping manage QA union inspectors when needed
Minimum Education: B.S. Chemistry or related science
Minimum Years of Experience: 1-3 years of Cosmetic or related industry experience
Special Requirements of the Position: French speaking a plus
Communication skills (both internal and external)
Senior Regulatory Specialist Jobs
By Cerberus Capital Management At New York, NY, United States
Must have intermediate to advanced excel skills; macro experience is preferred
Research new regulatory developments and reporting requirements
Must be analytical, detail oriented and have excellent communication skills
Experience with Accounting preferred but not required
Analyze the various data components within our SAP Business Objects proprietary Datawarehouse
Prepare regulatory filings with multiple government agencies including Form PF, Form SLT, Form Tic-B, Form PQR, Canadian filings, Annex IV
Regulatory Data Specialist Jobs
By FEFA, LLC At Fairfax, VA, United States
Experience performing data entry functions a must
Work closely with the production managers to ensure and document standard operating procedures that support data quality and production efficiency
A high school diploma (an Associate degree is preferred) with a minimum of two years of related experience.
Understand transcribing procedures and relevant state-of-the-art data entry/computer equipment.
Apply regulatory standards and prepare data for output to a variety of printed and electronic media
Maintain accurate and up-to-date documentation of project details
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 Specialist Jobs
By iLocatum At Greater Houston, United States
10-15 years experience in Regulatory within offshore pipelines, preferably OCS
Must be ok with working in an in-office setting
Can work with minimal supervision
Must be US Citizen / US Perm Resident
Must be within a commutable distance
OCS GOM shelf permitting / pipeline permitting