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2114 Management Jobs in United States

The Applicant Manager
CRO Regulatory Specialist

Location Boston, Massachusetts

 
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Ruekert & Mielke, Inc
Municipal Engineering Team Leader

Location Iowa City, Iowa

Other
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Auburn Washburn School District
Assistant Manager (#8202) - 1702 Louise Lane Pearsall TX

Location Pearsall, Texas

Full Time
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AHRC Nassau
Assistant Manager- Glen Cove New Woods location Tues - Thurs 3p-11p, Fri, Sat 7a-3p 40 hrs per week

Location Glen Cove, New York

Full Time
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Community Medical Center
Quality -Director of Quality

Location Missoula, Montana

Full Time
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SGS & Co
Account Director

Location Cincinnati, Ohio

Full Time
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EMCOR
Facility Manager

Location Mobile, Alabama

Contractor, Full Time
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JMT
Transportation Construction Manager

Location Camp Hill, Pennsylvania

Full Time, Contractor
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Metz Strategic Solutions
Concrete Workers-Supervisor, Walls, Flatwork, and Polishers/Stampers

Location Chambersburg, Pennsylvania

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Smarte Carte Inc.
Supervisor - SFO San Francisco Airport - Full-time

Location San Francisco, California

Full Time
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Broadmead Medical Services Inc
Regional Director of Operations (RDO)

Location Los Angeles, California

Full Time
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Advanced Decision Vectors, LLC
Deputy, SAF/IA Country Director Support (Indo-Pacific Division)

Location Washington, District of Columbia

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Kabat Schertzer & Company Pa
Tax Supervisor - Miami, FL (Dadeland)

Location Miami, Florida

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Broadmead Medical Services Inc
Assistant Manager(01842) 219 Main Gate Rd

Location Box Elder, South Dakota

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Broadmead Medical Services Inc
Director, Client & Delivery Excellence

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Care New England
Nursing Director - ACU

Location Providence, Rhode Island

 
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Broadmead Medical Services Inc
Assistant Manager(04901) - 1210 S. Blanding Blvd.

Location Orange Park, Florida

Full Time
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Tephra
Position Details: Director Business Development MedTech Manufacturing Engineering

Location Chicago, Illinois

 
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Tephra
Position Details: DIRECTOR OF CARE MANAGEMENT

Location Geneva, New York

 
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Midwestern State University
Director, Institutional Effectiveness

Location Wichita Falls, Texas

 
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Broadmead Medical Services Inc
Assistant Manager(07310) - 5720 Cleveland Blvd., Suite 101

Location Caldwell, Idaho

Full Time
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Auburn Washburn School District
Director of Revenue Management

Location Pittsburgh, Pennsylvania

Full Time
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Eliot
CBHC Clinical Supervisor- Youth Team

Location Haverhill, Massachusetts

Full Time
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University of Alaska
Director of Dining Services and Contract Operations

Location Fairbanks, Alaska

Contractor, Full Time
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Auburn Washburn School District
Assistant Manager - Optical

Location Abington, Pennsylvania

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The Applicant Manager
The Applicant Manager

CRO Regulatory Specialist

location Boston, Massachusetts

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CRO Regulatory Specialist Job Description
The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors and sites in meeting FDA, ICH, and GCP requirements. This role serves as the liaison between clinical operations, quality assurance, and regulatory authorities.
Reports to: Evidence Generation Leadership

Qualifications & Education Education:
Bachelor's degree (required) in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Master's degree preferred.
Experience: Minimum 5 years in clinical research with 3+ years in regulatory affairs at a CRO or sponsor.

Certifications: RAC (Regulatory Affairs Certification) preferred. Current GCP training certification required. Regulatory Knowledge: Deep understanding of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312/812), ICH GCP guidelines (E6(R3)), and global regulatory requirements.

Key Skills & Competencies
Technical Expertise Regulatory Submissions ICH/GCP Guidelines SOP Development Compliance Assessments
Problem Solving Risk Management Quality Management Systems Professional Attributes Critical Thinking Attention to Detail Cross-functional Collaboration Written/Verbal Communication Time Management A key role ensuring regulatory compliance throughout the clinical trial lifecycle, maintaining GCP standards, and supporting inspection readiness.

Position Overview Core Responsibilities
GCP Compliance & Quality Oversight Develop and maintain quality management systems that ensure protocol adherence
Conduct GCP compliance assessments and site readiness evaluations
Lead the implementation of risk-based monitoring strategies
Coordinate CAPA development and implementation for compliance issues
Regulatory Documentation & Submissions Prepare and review regulatory submission documents (IND/IDE, amendments)
Ensure completeness and compliance of essential documents
Manage regulatory document workflows and tracking systems
Support eTMF management for inspection readiness

Study Oversight & Data Management
Support data integrity initiatives following ALCOA+ principles
Facilitate audit trail review and documentation
Collaborate on validation of computerized systems (CTMS, EDC)
Create regulatory guidance for emerging technologies and data sources

Performance Expectations
Maintain 100% compliance with regulatory requirements across assigned studies
Successfully support regulatory inspections with minimal or no critical findings
Develop and maintain effective relationships with sponsors, sites, and regulatory authorities
Contribute to continuous improvement of regulatory processes and documentation systems

This role is critical to ensuring the CRO maintains its reputation for regulatory excellence and contributes directly to the successful approval of sponsors' drug development programs.
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