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
% of Time
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
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.
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. My 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.
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.
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.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
Equal Opportunity Employer Note: Job Postings are updated daily and remain online until filled.
Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.