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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

The work that keeps the world going

Who takes care of the healthcare supply chain? We do. Every day, we’re delivering what matters for healthcare customers—and patients—around the world. Our professionals make sure every step is executed with a level of expertise and service that has made us an industry leader. Join more than 6,000 healthcare logistics professionals who keep some of the most important packages in the world moving.

Benefits

  • Medical, Dental, Vision & more
    after 30 days

  • 401(K) plan with match

  • Growth from within

Benefits Disclaimer

The benefits and compensation information provided on this website are for informational purposes only. Not every product or service is available or applicable to every employee and the availability of a product or service is subject to change. UPS reserves the right to alter or delete the information provided as required by UPS’ business needs.

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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