Director of Regulatory Affairs
Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: July 12, 2025
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Job Description:
Director of Regulatory Affairs Job ID: req4330 Employee Type:
exempt full-time Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS Location: 5705 Industry Lane, Frederick,
MD 21704 USA The Frederick National Laboratory is operated by
Leidos Biomedical Research, Inc. The lab addresses some of the most
urgent and intractable problems in the biomedical sciences in
cancer and AIDS, drug development and first-in-human clinical
trials, applications of nanotechnology in medicine, and rapid
response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity
and Versatility; it's the FNL way. PROGRAM DESCRIPTION Within
Leidos Biomedical Research Inc., operator of the Frederick National
Laboratory for Cancer Research, the Clinical Monitoring Research
Program Directorate (CMRPD) provides high-quality comprehensive and
strategic operational support to high-profile domestic and
international clinical research initiatives sponsored by the
National Cancer Institute (NCI), the National Institute of Allergy
and Infectious Diseases (NIAID), the National Institutes of Health
(NIH), and several other institutes within NIH. CMRPD’s ability to
provide rapid responses and high-quality solutions, and to recruit
and retain experts with a variety of backgrounds, allows the
directorate to facilitate strategic support to the growing clinical
research portfolios of NCI, NIAID, and other NIH
divisions/offices/centers. CMRPD’s support services are aligned
with the program’s mission to provide comprehensive clinical trials
operations and program/project management services to advance
scientific clinical research that complies with applicable
regulations and guidelines, maintains data integrity, and protects
human subjects. CMRPD services include clinical trials monitoring,
regulatory affairs support, clinical safety oversight, protocol
navigation/protocol development, and programmatic and project
management support to facilitate the conduct of more than 400 Phase
I, II, and III domestic and international trials annually. These
trials investigate the prevention, diagnosis and treatment of
cancer, influenza, HIV, infectious diseases and emerging health
challenges like Ebola virus and COVID-19, heart, lung, and blood
disorders, parasitic infections, and rare and neglected diseases.
CMRPD’s collaborative approach to clinical research support and the
expertise and dedication of staff to the continuation and success
of CMRPD’s mission has contributed to improving the overall
standards of public health on a global scale. The Clinical
Monitoring Research Program Directorate (CMRPD) provides support to
multiple NIH institutes and divisions, this position will primarily
support DCR Office of Clinical Research Policy and Regulatory
Operations (OCRPRO) and the National Center for Advancing
Translational Sciences (NCATS). KEY ROLES/RESPONSIBILITIES
Responsible for directing regulatory staff and managing regulatory
activities for the Regulatory Compliance and Human Subjects
Protection Program (RCHSPP) within CMRPD, including managing
submission of regulatory documents to the FDA and other regulatory
authorities. Serves as a senior advisor to NCATS, OCRPRO, and NIAID
clinical investigators participating in regulatory discussions and
activities. Provides guidance and leadership for the establishment
of regulatory standards and templates for regulatory documents.
Interacts with clinical investigators, LBR and government team
leads and staff to facilitate clinical trials research. Provides
management oversight of activities conducted by a team of
regulatory affairs professionals. Reviews documents for content,
accuracy, and compliance with applicable regulations prior to
submission to regulatory agencies. Reviews OCRPRO policies for
content, accuracy, and compliance with applicable regulations.
Reviews clinical trial agreements, transfer of regulatory
obligations (TORO) documents, and other clinical and/or regulatory
agreements for content, accuracy, and compliance with applicable
regulations, NIH and OCRPRO policies. Prepares monthly, quarterly,
and annual status reports for assigned projects. Reviews and
approves and/or writes all new or modified SOPs and work
instructions to ensure regulatory compliance. Provides expert
assessments for problem solving utilizing information analysis and
regulation research. Evaluates regulatory systems, policies and
procedures, training programs, and staff to assure continued
compliance with regulatory agencies and procedures. Evaluates and
monitors performance of regulatory staff to meet regulatory
requirements, minimize risks, and to comply with SOPs. Supervises
and mentors a staff of technical personnel. Oversees the effective
use of available resources and incorporates time management
practices to meet established goals and deadlines. Prepares,
reviews, and manages budgets for RCHSPP Regulatory Affairs group
and NCATS projects. Develops regulatory presentations and training
materials for NIAID investigators, CMRPD staff, and outside
researchers. Interprets FDA and other regulatory authority
policies, procedures and regulations in assigned areas of
responsibility. This position is on-site Industry
Lane/hybrid/local. BASIC QUALIFICATIONS To be considered for this
position, you must minimally meet the knowledge, skills, and
abilities listed below: Possession of a bachelor’s degree from an
accredited college/university in a field related to biomedical
research/clinical trials/health or ten (10) years related
experience in lieu of degree. Based on program requirements,
certified regulatory, IRB, or clinical research professional
preferred. In addition to educational requirements, a minimum of
ten (10) years directly related experience (industry/pharmaceutical
research and development and/or FDA experience) including a minimum
of eight plus (8) years directly managing multiple concurrent
clinical projects. Foreign degrees must be evaluated for U.S.
equivalency. Must be detail-oriented and possess strong
interpersonal, management, and organizational skills, and the
ability to prioritize multiple tasks/projects. Must possess
excellent written and oral communication skills and clinical trial
fieldwork concepts and practices. Must be well versed with a
comprehensive working knowledge of FDA regulations and guidelines
(CFR, ICH GCP guidelines, international regulations). Demonstrated
knowledge of data management collection, use of various databases,
report compilation for IND submissions, and overall management of
regulatory affairs. Knowledge of regulatory requirements and
guidelines for clinical research. Possess solid understanding of
the drug development process. Ability to provide senior-level
leadership in designing, leading, and directing. Strong working
command of MS Software. Possibility of Ability to audit and edit
written summaries of data for reports, presentations, and/or
publications. Must be able to obtain and maintain a security
clearance. REQUIRED SKILLS/EXPERIENCE In addition to education
requirements, a minimum of eight (8) years directly related
experience (industry/pharmaceutical research and development and/or
FDA experience). Must be detail-oriented and possess strong
interpersonal, management, and organizational skills, and the
ability to prioritize multiple tasks/projects. Must possess
excellent written and oral communication skills and clinical trial
fieldwork concepts and practices. Must be well versed with a
comprehensive working knowledge of FDA regulations and guidelines
(CFR, ICH GCP guidelines, international regulations, inspection
readiness). Demonstrated knowledge of data management collection,
use of various databases and eCTD software, report compilation for
IND submissions, and overall management of regulatory affairs.
Knowledge of regulatory requirements and guidelines for clinical
research requirements. Possess solid understanding of the drug
development process. Ability to provide senior-level leadership in
designing, leading and directing. Strong working command of MS
Software. Possibility of PREFERRED QUALIFICATIONS Candidates with
these desired skills will be given preferential consideration:
Ability to audit and edit written summaries of data for reports,
presentations, and/or publications. Commitment to
Non-Discrimination All qualified applicants will receive
consideration for employment without regard to sex, race,
ethnicity, color, age, national origin, citizenship, religion,
physical or mental disability, medical condition, genetic
information, pregnancy, family structure, marital status, ancestry,
domestic partner status, sexual orientation, gender identity or
expression, veteran or military status, or any other basis
prohibited by law. Leidos will also consider for employment
qualified applicants with criminal histories consistent with
relevant laws. Pay and Benefits Pay and benefits are fundamental to
any career decision. That's why we craft compensation packages that
reflect the importance of the work we do for our customers.
Employment benefits include competitive compensation, Health and
Wellness programs, Income Protection, Paid Leave and Retirement.
More details are available here 160,400.00 - 275,750.00 The posted
pay range for this job is a general guideline and not a guarantee
of compensation or salary. Additional factors considered in
extending an offer include, but are not limited to,
responsibilities of the job, education, experience, knowledge,
skills, and abilities as well as internal equity, and alignment
with market data. The salary range posted is a full-time equivalent
salary and will vary depending on scheduled hours for part time
positions
Keywords: Frederick National Laboratory for Cancer Research, Olney , Director of Regulatory Affairs, Science, Research & Development , Frederick, Maryland