Regulatory Affairs Associate II

About the role

The Regulatory Affairs Associate supports regulatory strategy and operations to ensure IND filing readiness for translational programs, FDA clearance for clinical testing, and regulatory filings during clinical trials. This role works closely with Leidos Biomed/DDD leadership, NIH team members, SMEs, CROs, and external collaborators and vendors.

Responsibilities

• Support the Drug Discovery and Development (DDD) program initiatives that include regulatory affairs activities to meet expectations for operational performance and project success.
• 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.
• 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.
• 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; escalate 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.

Qualifications

• 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.
• 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.
• 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.
• 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.