• Regulatory Affairs Specialist I

    Posted Date 1 month ago(1 month ago)
    Requisition ID
    2018-43891
    Category
    Professional
    Position Type
    Regular Full-Time
    Department
    RESH Regulatory Affairs Unit
    Post End Date
    8/20/2018
  • Overview

    The Regulatory Affairs Specialists I is an entry-level position responsible for preparing initial FDA submission as well as subsequent filing including but not limited to modified protocols, consent forms, serious adverse events (SAEs), and annual progress reports (APRs). The Regulatory Affairs Specialists I works under immediate supervision of the Regulatory Affairs Unit Manager. Because this is an entry level position, it will be expected that the Regulatory Affairs Specialist I will learn and apply relevant parts of the Code of Federal Regulations (e.g. 21 CFR 312, 21 CFR 812, etc.). 

     

    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: Negotiable

     

    Responsibilities

    1. Prepares, submits, and maintains regulatory documents required for UAMS sponsored IND/IDE applications and files. 
    2. The Regulatory Affairs Specialist I manages 3-10 IND/IDE projects. Relies on instructions and pre-established guidelines to perform the functions of the job; limited interface with external regulatory agencies.  Primary job functions do not typically require exercising independent judgment.  
    3. Assists in the development of presentations to research personnel. 
    4. Assists in the development of forms and templates.
    5. Assists in the development of Policies and Procedures for the Regulatory Affairs Unit and Office of Research Regulatory Affairs. 
    6. Participates on project development teams and interfaces with functional personnel to effectively communicate regulatory requirements. 
    7. Accepts other assignments as deemed necessary by the Regulatory Manager or ORRA Director.
    8. May perform other duties as assigned.

    Qualifications

    Minimum Qualifications:

    • Bachelor's degree (preferred) in one of the life, natural or clinical sciences
    • Membership in RAPS within 12 months of hire date
    • Clinical Research Specialists certification or willing to enroll when hired and maintenance of that certification.

    Preferred Qualifications:

    • Regulatory Certificate Program or degree in regulatory science.

     

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

     

    Physical Requirements

    Stand: Occasionally
    Sit: Continuously
    Walk: Occasionally
    Bend, crawl, crouch, kneel, stoop, or reach overhead: Never
    Lift, push, pull, carry weight: 10 lbs or less
    Use hands to touch, handle, or feel: Continuously
    Talk: Continuously
    Hear: Continuously
    Taste or smell: Never
    Read, concentrate, think analytically: Continuously
    Physical Environment: Inside Office Environment
    Noise Level: Quiet
    Visual Requirements: Near visual acuity
    Hazards: None

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