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HC Regulatory Affairs Specialist

  • Full-Time
  • Newark, Delaware
  • Travel: No
  • Facility: Newark
  • Job ID: 271962
  • Zip Code: 19702
  • Street Address: 211 LAKE DRIVE

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  • Medical, Dental, Vision & more
    after 30 days

  • 401(K) plan with match

  • Growth from within

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HC Regulatory Affairs Specialist

  • Full-Time
  • Newark, Delaware
  • Facility: Newark
  • Job ID: 271962
  • Zip Code: 19702
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Date posted 06/15/2021

The Regulatory Affairs (RA) Specialist for controlled substances and listed chemicals will perform duties associated with Suspicious Order Monitoring (SOM) process on all controlled substance and/or listed chemical product orders, evaluate orders for UPS Supply Chain Solutions (SCS), and/or perform duties relating to Know Your Customer (KYC) review, inventory reconciliation, complete importing/exporting documents, and submit required reports to state and Federal agencies.

Responsibilities and Duties

  • Performs the SOM order evaluation on containing controlled substances and/or listed chemical products
  • Escalates order and/or customer concerns to regulatory management
  • Evaluates and researches orders
  • Conducts internal evaluations
  • Obtains information from customer, client, and/or UPS SCS internal departments as needed for completing evaluations
  • Ensures suspicious orders are canceled in the order management system
  • Assists with responding to client or internal staff regulatory inquiries or concerns
  • Assists with documentation, procedures, and reports
  • Helps review and write standard operating procedures (SOP) or work instructions specific to regulatory requirements
  • Completes import and export forms for controlled substance products being imported or exported outside of the U.S.
  • Prepares, reviews, and maintains KYC files
  • Reconciles controlled substance inventories prior to sending transactional reports to DEA and/or state agencies
  • Generates and submits required transactional reports to DEA and state agencies
  • Reviews and maintain copies of any written communication to any agencies

Knowledge and Skills

  • Experience in pharmaceutical or healthcare industry in a regulatory/ quality related role
  • Experience with the proper handling and distribution of pharmaceutical controlled substances and compliance requirements regarding the same
  • Experience with DEA, State Regulatory Agencies and FDA
  • Superior attention to detail
  • Positive influence and negotiation skills
  • Strong investigation and research skills
  • Strong legal, regulatory and compliance knowledge
  • Strong verbal and written communication
  • Strong technical writing skills
  • Strong organization, time management and planning
  • Basic proficiency in MS Word and Excel
  • Proficiency in English 
  • Proficiency in second language - Preferred
  • Associate's Degree in Biology, Chemistry, or other science related discipline - Preferred

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law
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