• Regulatory Affairs Manager

    Posted Date 2 weeks ago(2/10/2020 10:13 AM)
    Requisition ID
    2020-64522
    Category
    Research
    Position Type
    Regular Full-Time
    Department
    RESH Regulatory Affairs Unit
    Post End Date
    3/10/2020
  • Overview

    The primary responsibility of the Regulatory Affairs Manager is assuring the management, retention, and control of all applicable IND/IDE submissions made to the U.S.Food and Drug Administration (FDA);supervision and training of Regulatory Specialists; independent execution of regulatory-related decisions/strategies; and coordinate work with the ORRA Study Monitors to assure that FDA deadlines are met.  The manager must have advanced ability to coordinate multiple projects through effective oral and written communication.  Extensive knowledge of FDA law and regulations in particular 21 CFR11, 50, 54, 56, 312, and 812 are required.

     

    All UAMS employees will treat others with Dignity and Respect.  We communicate and share complete and unbiased information, assuring our colleagues receive timely, complete, and accurate information in order make informed decisions. 

    We participate in institutional initiatives and encourage the participation of others.  We collaborate in policy and program development, implementation, and evaluation using best practices in delivering quality service. 

     

    The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity.  We champion being a collaborative health care organization, focused on improving the health, health care, and well-being of Arkansans.  

     

    UAMS offers amazing benefits and perks:

    • Health: Medical, Dental and Vision plans available for staff and family
    • Holiday, Vacation and Sick Leave
    • Education discount for staff and dependents (undergraduate only)
    • Retirement: Up to 10% matched contribution from UAMS
    • Basic Life Insurance up to $50,000
    • Career Training and Educational Opportunities
    • Merchant Discounts
    • Concierge prescription delivery on the main campus when using UAMS pharmacy

    Salary:  offered commensurate with experience

    Responsibilities

    • Assures the proper management, retention, and control of all applicable Regulatory Affairs submissions pertaining to investigator-initiated INDs and IDEs as well as exemption requests. 
    • Ensures that all regulatory documents are prepared in accordance with regulatory guidelines. 
    • Reviews IND/IDE submissions and potential submissions for Investigator-Initiated research that are conducted under a UAMS-sponsored IND or IDE. 
    • Supervises, trains, and evaluates Regulatory Affairs Specialists.  
    • Develops policies and Procedures for the Unit, Research Regulatory Affairs, and UAMS Policy where applicable.  
    • Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions.  
    • Interacts with project team members to define submission logistics and workflow scheduling.  
    • Responsible for the oversite of the ongoing maintenance of records detailing the number of active INDs and IDEs and related data; preparation of the annual summary of work products for ORRA.  
    • Other duties as assigned.

    CORE COMPETENCIES:

    • Extensive knowledge of FDA regulations pertaining to INDs and IDEs.
    • Ability to manage complex projects requiring teamwork.
    • Excellent verbal and non-verbal communication skills.
    • Ability to train and motivate employees.
    • Detailed understanding of clinical research.

    Customer Service: 

    • Interacts with and assists the public in a professional and friendly manner as needed. 
    • Demonstrates effective communication skills; communicates accurate and complete information' maintains strict confidentiality when necessary. 
    • Demonstrates positive working relationships with co-workers, management team, and ancillary departments; follows the Core Concepts of Patient and Family Centered Care and the Basic Code of Conduct Guidelines.
    • Assists internal and external stakeholders as needed with exceptional customer service.

    Qualifications

    Minimum Qualifications: 

    • Bachelor degree in regulatory, natural, or life science plus 5 years experience in a regulatory position, especially IND/IDE regulatory affairs.

    Knowledge, Skills, & Abilities: 

    • Advanced ability to coordinate multiple projects and flexibility in adjusting daily workload priorities.
    • Advanced ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
    • Ability to demonstrate excellent judgment, organizational, leadership, reasoning, and interpersonal skills.
    • Advanced ability to lead and motivate others; ability to meet deadlines, take initiative and make decisions within internal/external guidelines.
    • Extensive knowledge of FDA regulatory requirements, specifically 21 CFR 11, 50, 54, 56, 312, and 812; ability to function in a controlled environment regulated by FDA and to handle confidential data.
    • Advanced ability to demonstrate computer-literacy in Microsoft Outlook, Word, Excel and Adobe Acrobat.
    • Advanced ability to demonstrate by example leadership in job performance.
    • Accept and follow the Regulatory Affairs Professional Code of Conduct.

    Preferred Qualifications: 

    • PhD or Masters degree in regulatory, natural, or life science.
    • Regulatory Affairs Certification; will accept CCRA, CCRC, or equivalent.

    UAMS is an Affirmative Action and Equal Opportunity Employer of individuals with disabilities and protected veterans and is committed to excellence.

     

    #CB

    Physical Requirements

    Stand: Occasionally
    Sit: Frequently
    Walk: Occasionally
    Bend, crawl, crouch, kneel, stoop, or reach overhead: Occasionally
    Lift, push, pull, carry weight: 11 - 25 lbs
    Use hands to touch, handle, or feel: Occasionally
    Talk: Frequently
    Hear: Frequently
    Taste or smell: Never
    Read, concentrate, think analytically: Continuously
    Physical Environment: Inside Classroom Setting, Inside Office Environment
    Noise Level: Quiet
    Visual Requirements: Near visual acuity
    Hazards: None

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