Regulatory Affairs Associate II

Location: Onsite at 9800 Medical Center Dr, Rockville, MD 20850, USA

Salary: $69,800–$100,045 annual salary

Company

hirify.global is operated by Leidos Biomedical Research and supports biomedical research, drug development, clinical trials, and translational science programs.

What you will do

• Support regulatory strategy and operations for translational programs progressing from preclinical, IND-enabling studies to clinical development.
• Draft, coordinate, review, compile, and finalize IND and other regulatory submission materials for FDA, Health Canada, and EMA interactions.
• Prepare documentation including FDA incentive applications, INTERACT and pre-IND meeting packages, Investigator Brochures, CMC and nonclinical summaries, toxicology reports, protocols, and preclinical study reports.
• Coordinate regulatory deliverables with NIH teams, subject matter experts, CROs, external vendors, and collaborators.
• Maintain document control, version control, submission trackers, and audit- and inspection-ready records.
• Identify documentation gaps, inconsistencies, risks, and timeline issues and support their resolution.

Requirements

• Bachelor's degree in biomedical research, drug development, clinical research, health, or a related field, or four years of related experience in lieu of a degree.
• At least two years of regulatory affairs, regulatory operations, or regulatory submission support experience in a pharmaceutical, biotechnology, CRO, government contractor, or related biomedical environment.
• Hands-on experience preparing regulatory documentation for drugs and/or biologics, including cell and gene therapies, and assembling submission-ready materials.
• Knowledge of 21 CFR Part 312, GLP requirements, and regulatory expectations for IND-enabling preclinical development.
• Experience coordinating cross-functional regulatory deliverables and strong organizational, technical writing, communication, planning, and problem-solving skills.
• Ability to obtain and maintain a security clearance.

Nice to have

• Advanced degree or regulatory affairs certification such as RAC.
• At least five years of relevant regulatory affairs or submission support experience.
• Experience with FDA IND submissions, EMA submissions, IND Modules 1–5, eCTD structure, submission publishing, or regulatory document management systems.
• Experience in preclinical development, toxicology, bioanalytical, pharmacology, CMC, or IND-enabling study documentation.
• Experience with federally funded research, government contracts, Microsoft Project, SharePoint, or Teams.

Culture & Benefits

• Values include accountability, compassion, collaboration, dedication, integrity, and versatility.
• Employment benefits include health and wellness programs, income protection, paid leave, and retirement benefits.
• Work involves collaboration across NIH, Leidos Biomedical, academic, nonprofit, pharmaceutical, biotechnology, CRO, and vendor stakeholders.