Regulatory Affairs Associate II

Regulatory Affairs Associate II Job ID: req4628 Employee Type: exempt full-time Division: Clinical Research Directorate Facility: Rockville: 9800 MedCtrDr Location: 9800 Medical Center Dr, Rockville, MD 20850 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., the Drug Discovery and Development (DDD) program in the Clinical Research Directorate (CRD) provides project and operational management of initiatives in support of the National Center for Advancing Translational Sciences (NCATS). NCATS supported efforts include management of the Therapeutics Development Branch (TDB) drug development programs such as gene therapies and rare disease therapeutic candidates. NCATS stimulates drug discovery and development collaboration between NIH, Leidos, academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies. NCATS supported efforts include preclinical and IND-enabling development programs across drug and biologic candidates, including activities requiring coordination among multiple NIH teams, subject matter experts (SMEs), contract research organizations (CROs), and external vendors. DDD supports efficient preparation of regulatory materials and documentation needed for IND and other regulatory submissions.

KEY ROLES/RESPONSIBILITIES

The Regulatory Affairs Associate will support regulatory strategy and operations to ensure IND filing readiness for translational programs, FDA clearance for clinical testing, and regulatory filings during clinical trials. The position will support coordination, document control, timeline tracking, writing, review, compilation, and finalization of materials required for IND and other submissions (INTERACT, pre-IND, Type C meetings, etc.) to regulatory bodies, such as FDA, Health Canada, and EMA. The regulatory affairs associate will work closely with Leidos Biomed/DDD leadership, NIH team members, SMEs, CROs, and external collaborators and vendors to ensure regulatory documents are accurate, consistent, complete, and organized for submission and inspection. Responsibilities include but are not limited to: Support the Drug Discovery and Development (DDD) program initiatives that include regulatory affairs activities to meet expectations for operational performance and project success. Use technical and strategic regulatory experience to work closely with the DDD leadership and NIH team members to advance translational projects from preclinical (IND-enabling) studies to clinical stage, including the development of regulatory strategies integrated with project scope and timelines, as well as preparation and review of documentation, as further detailed below. Guide regulatory strategy in alignment with the program goals, including for rare diseases, in collaboration with DDD and NIH teams. Prepare, draft, coordinate, review, and finalize documentation such as FDA incentive applications (Orphan Drug Designation, Rare Pediatric Disease Designation), INTERACT, pre-IND, and other FDA meeting packages, Investigator Brochures, General Investigational Plans, CMC summaries, non-clinical summaries, toxicology reports, study protocols, bioanalytical reports, and preclinical study reports needed to support INDs and other regulatory submissions for NIH translational projects (drug or biologic therapeutic candidates, cell and gene therapies, or devices). Work closely with Subject Matter Experts, CROs, collaborators, external vendors, Leidos Biomed/DDD leadership, and NIH team members in all regulatory activities. Ensure consistency, accuracy, completeness, version control, and compliance of documentation. Maintain efficient document control processes, submission-ready files, document status trackers, and audit/inspection-ready records including documentation generated by CRO and NIH teams, study deliverables, and timelines related to regulatory activities. Identify documentation gaps, inconsistencies, risks, and timeline issues; escalated concerns through Leidos Biomed/DDD management and support resolution. Support regulatory readiness meetings, document planning meetings, and submission preparation activities. Ensure regulatory work assignments and frequent guidance/direction are managed through the applicable Leidos Biomed supervisor and appropriate task order mechanisms. Perform other related regulatory operations and documentation support duties as assigned by Leidos Biomed/DDD management.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: A bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/drug development/clinical research/health, or four (4) years related experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirement, a minimum of two (2) years of regulatory affairs, regulatory operations, or regulatory submission support experience in a pharmaceutical, biotechnology, CRO, government contractor, or related biomedical development environment. Hands‑on experience writing, coordinating, and supporting regulatory documentation preparation for drugs and/or biologics (including cell and gene therapy), as well as coordination and assembly of submission‑ready regulatory documentation. Demonstrated knowledge of 21 CFR Part 312, GLP requirements, and regulatory expectations for IND-enabling preclinical development programs. Experience working with CROs, external vendors, SMEs, and cross‑functional project teams to obtain, review, track, and finalize regulatory deliverables. Experience drafting, reviewing, tracking, or coordinating regulatory documents such as Investigator Brochures, General Investigational Plans, CMC summaries, nonclinical summaries, toxicology reports, study protocols, bioanalytical reports, and preclinical study reports. Strong organizational, document control, version control, and records management skills in a fast‑paced, cross‑functional development environment. Excellent written and oral communication skills, including strong technical writing, editing, and meeting coordination skills. Strong interpersonal and cross‑functional communication skills with the ability to coordinate input from scientific, regulatory, operational, and vendor stakeholders. Expertise in planning, issue tracking, timeline management, prioritization, and problem solving. Ability to work effectively both independently and as a team member, with consistent ability to take initiative and make an active contribution to team performance. Demonstrated proficiency in Windows and Microsoft Office Suite, including Word, Excel, Project, PowerPoint, Outlook, and document management/tracking tools. Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration: Advanced degree (master's or PhD) or regulatory affairs certification, such as RAC, in a relevant scientific or regulatory discipline. A minimum of five (5) years of regulatory affairs, regulatory operations, or regulatory submission support experience. Experience with FDA IND submissions and/or EMA regulatory submission support for drugs, biologics, gene therapies, or advanced therapeutic candidates. Experience supporting IND Modules 1-5, eCTD structure, submission publishing, quality control checks, or regulatory document management systems. Experience in preclinical development, toxicology, bioanalytical, pharmacology, CMC, or IND-enabling study documentation. Experience supporting federally funded research or government contract environments. Familiarity with Federal Acquisition Regulations and contractor/government operating boundaries. Knowledge of Microsoft Project, SharePoint, Teams, or other collaboration and document tracking tools used to execute project requirements. 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

69,800.00 - 100,045.00 USD

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 #J-18808-Ljbffr Initial Therapeutics, Inc.