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UPS HC Regulatory Affairs Specialist in Newark, Delaware

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

Company: UNITED PARCEL SERVICE

Category: Operations, Full Time

Requisition Number: 271962

Location: Newark,Delaware

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