The Regulatory Affairs Officer will serve as the Director of Regulatory Affairs for the HIV Prevention Trials Network (HPTN) Laboratory Center (LC). This position will serve as the primary point of contact and liaison with laboratories and Cores within the HPTN, and provide leadership and oversight to ensure regulatory compliance with laboratory operations.
The regulatory affairs officer will ensure that activities within the HPTN LC meet legislative and appropriate oversight requirements. The Regulatory Affairs Officer will be responsible for maintaining a current knowledge of regulatory guidance, including, but not limited to, the United Stated Food and Drug Administration, European Medical Agencies, International Council for Harmonization, International Organization for Standardization, the South African Health Products Regulatory Authority, and the United Kingdom Medicines and Healthcare Products Regulatory Agency, amongst others. They will be able to review and audit for institutional training, completeness of laboratory-specific training, and competency compliance for personnel within the HPTN LC. They will be able to demonstrate good writing skills in order to develop Standard Operating Procedures (SOP), participate in Request For Proposals (RFP) responses and produce internal and external audit reports ready for final edit. Role requires interaction with JHU Office of Research Administration (ORA), Purchasing and the Comptroller's office as well as established networks of senior level laboratory professionals, other network personnel (including the HPTN statistical and data management center and leadership and operations center), donors/sponsors with awareness for working in multiple socio-economic settings and with multi-cultural groups in developing countries.
This role will also work with the ORA and HPTN finance leadership in the maintenance of contracts and material/specimen transfer agreements.
DUTIES AND RESPONSIBILITIES
Generate and maintain overarching HPTN LC Standard Operating Procedures
Lead and coordinate standardization across the HPTN LC re: appropriate language and practice on the requirements for document retention, instrument maintenance records, and safety, in compliance with appropriate institutional and regulatory guidelines
Review overarching HPTN LC laboratory specific SOPs to ensure compliance with federal regulations
Collate and maintain a centralized repository for HPTN LC staff institutional and governance training and refreshers, as per institutional and funding agency requirements
Remain up to date with changes in regulatory legislations and guidelines
Review, communicate, and disseminate appropriate recommendations from national and international oversight organizations (ie. US FDA, EMA, ICH, ISO, etc.).
Interact with ORA for HPTN LC subcontracts and material/specimen transfer agreements
Review HPTN LC subcontracts/purchasing agreements and ensure that they are current
Store, maintain and work with HPTN and institutional finance leaders on appropriate contract and agreement documents.
Coordinate internal and external audits and summarize findings for laboratories within the HPTN LC.
Coordinate and finalize responses for external HPTN LC audits, with appropriate JHU staff in purchasing, comptroller's office and ORA.
Draft corrective action plans with HPTN LC Leadership.
Execute and monitor HPTN LC corrective action plans.
Oversee the management of quality improvement initiatives within HPTN LC laboratories.
Liaise and hold negotiations with regulatory authorities
Provide advice about regulations to laboratories within the HPTN LC
Ensure that appropriate quality standards are met and regulatory/vendor submissions meet strict deadlines
10% Administrative Duties
Prepare and distribute meeting agenda focused on regulatory compliance to HPTN LC laboratories
Provide educational materials to members of the HPTN LC with regards to regulatory compliance.
Lead in-services on regulatory updates.
Draft regulatory language for HPTN LC-related manuscripts and grants.
Prepare documentation for regulatory/vendor submissions.
Qualifications: JD from an accredited law school and a member of the Bar of the State of Maryland in good standing (or admitted to the bar of another state) required. May consider candidate with PhD. degree with significant regulatory/industry experience. Three years progressive responsibility in a regulated environment, which may include industry or government. Regulatory oversight and familiarity with US FDA, EMA, ISO and ICH guidance. Strong organizational skills, writing and editing abilities and high level computer skills required.
Preferred: Exposure to working internationally or supporting international projects preferred.
Special Knowledge, Skills, or Abilities / Competencies:
An understanding and appreciation of relevant legal, scientific, and manufacturing areas is also necessary.
Experience working with Federal regulations and sponsored projects for educational institutions.
Familiarity with the regulatory agencies involved in human research and pertinent laws and regulations as well as the ethical considerations related to that subject highly desirable. Must have the ability to apply regulatory requirements to proposed research protocols, exhibit skills in conducting research using electronic methods, and possess exemplary writing and verbal skills. Experience in group process and dynamics.
Excellent verbal and written communication skills required. Excellent organizational skills, strong attention to detail and the ability to manage multiple tasks simultaneously required. Excellent interpersonal skills and cultural sensitivity required. Strong computer and IT skills.
Experience in project management, and international research or projects preferred. Formal training in project management and strong knowledge of project management software programs.
Comprehensive knowledge of SAP, accounting system practice and/or implementation. Knowledge of accounting and budget practices.
Experience in international travel and logistics arrangements.
Ability to work independently in a small team environment, but also to collaborate with other office members and outside contacts in the pursuit of team goals.
Classified Title: Regulatory Affairs Officer Role/Level/Range: ATP/04/PE Salary: $68,456 - $94,063 Status: Full-Time Department name: 10003068-SOM Pat HIV Clinical and Research Work Schedule/Hours: M-F 8:00 - 4:30 Location: 04-MD:School of Medicine Campus Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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