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Senior Regulatory Manager

System One
New Haven, CT
  • Posted: over a month ago
  • Full-Time
Job Description
Title: Senior Regulatory Manager
Location: New Haven, CT (will consider remote candidates)
Duration: Direct Hire
Schedule: M-F 37.5 hours, occasional evening and weekend hours
Target Start Date: ASAP

Responsibilities:
  • Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department.
  • Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed.
  • Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments.
  • Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments.
  • Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies.
  • Manages administrative support for activities of one or more departments to ensure timely completion of projects.
  • Manages and coordinates training sessions for assigned departments when new policies or practices are adopted.
  • Ensures compliance with federal regulations as they apply to the assigned departments.
  • Identifies, plans, and develops administrative policies for the assigned departments.
  • Assists in reviewing and implements departmental policies as they pertain to the administrative functions of the assigned department.
  • Assesses and makes recommendations regarding staff development and staffing levels.
  • Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis.
  • Manages a staff of exempt and non-exempt employees.
Requirements:

Preferred:
  • BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
  • Ability to clearly communicate and understand written information.
  • Ability to analyze ideas, use logic, and recognize the nature of issues to develop creative problem-solving opportunities.
  • Ability to motivate, develop, and assess learning capacity of direct reports.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


System One

Address

New Haven, CT
USA

Industry

Government

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