Manager, DEA Regulatory Affairs

Company: Quva Pharma
Location: Bloomsbury
Posted on: February 22, 2021

Job Description:

Position Overview:QuVa Pharma is seeking a motivated and organized Manager, DEA Regulatory Affairs for its Bloomsbury, New Jersey site. The ideal candidate will have specific expertise in storage, handling and transfer of controlled substances. Responsibilities may include:

• Responsible for regulatory compliance with the DEA
• Responsible for timely and accurate filing of DEA reports, filings and notifications for the Bloomsbury site
• Responsible for timely and accurate filing of state-controlled substance reports, filings and notifications for the Bloomsbury site
• Assists in inspections and audits and serves as an SME for all DEA related SOPs. Reviews guidance documents and makes recommendations
• Ensures consistency with reporting and processes for all QuVa Pharma sites
• Heads the DEA compliance and reporting for all Bloomsbury activities including laboratory
• Supervises ARCOS and YERS reporting, ensures DEA compliance with bulk intermediate shipping, tracks quotas, heads DEA related CAPA investigations
• Ensures that all site personnel with access to the vault and controlled substances are in compliance with requirements and training
• Responsible for the annual controlled substance inventory for the Bloomsbury site
• Other responsibilities include assisting in SOP development, special projects, audits and regulatory filings
• Establishes and maintains cooperative cross-functional relationships with peers across all sites in Quality, Operations, Customer Service, and Technical Operations to meet site and corporate objectives
• Performs other duties as assigned by Management Qualifications:
  • Legally authorized to work in the job posting country
  • B.S. in a Scientific discipline, Pharmacy preferred
  • Minimum of 5 years of experience working with Controlled Substances required To be considered:In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date. Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire. It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Keywords: Quva Pharma, Bethlehem , Manager, DEA Regulatory Affairs, Executive , Bloomsbury, Pennsylvania