The Division of Therapeutics and Medical Consequences (DTMC) of NIDA supports and conducts studies to evaluate the safety and efficacy of new pharmacotherapies, biologics, behavioral therapies, devices, and digital therapeutics for Substance Use Disorders (SUDs). DTMC supports research through peer-reviewed grants and contracts for all stages of medications development including preclinical evaluation of potential therapeutics, clinical trial design and execution, and the preparation of regulatory submissions. The Regulatory Affairs Branch provides expert regulatory guidance and consultation in support of DTMC's medications development efforts.
Regulatory Affairs: The incumbent serves as a Supervisory Regulatory Affairs Specialist specializing in Regulatory Affairs within the Branch. The Supervisory Regulatory Affairs Specialist is responsible for providing regulatory expertise and strategies and serves as a liaison between DTMC and other regulatory agencies and organizations (e.g., Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Institutional Review Boards (IRBs), and Data Safety Monitoring Boards), research sponsors and collaborators, academic investigators, pharmaceutical companies, and clinical research organizations. The HSA participates in the collection and review of study-specific documents (i.e., research protocols, informed consent documents, etc.) and leads the preparation of regulatory submissions (Investigational New Drug Applications (INDs), Drug Master Files (DMFs), New Drug Applications (NDAs), including amendments, supplements, annual reports, and safety reports. The Supervisory Regulatory Affairs Specialist may serve as a Contracting Officer Representative (COR) with delegated authority to act as a government representative in monitoring specified aspects of contractor performance in meeting the standards set forth in the contract such as technical, performance, and budgetary requirements. The Supervisory Regulatory Affairs Specialist may also serve as Project Officer/Science Officer to provide scientific and administrative stewardship of extramural grant applications.
How to apply? Applications will be accepted via the Supervisory Regulatory Affairs Specialist vacancy announcement on USAJOBS.gov.
Interested? Please contact Aida Klun, firstname.lastname@example.org, and 301.827.5929 for more information concerning this position.
A full Civil Service package of benefits (including retirement, health, life, and long-term care insurance, as well as Thrift Savings Plan, etc.) is available. DHHS, NIH, and NIDA are equal opportunity employers. Applications from women, minorities, and persons with disabilities are strongly encouraged.