Job Overview
Program Management and Technology Services, Inc. (PMTS) is seeking multiple Regulatory Affairs Scientists to support the Defense Health Agency (DHA) Research and Development MRDC Office of Regulated Activities (ORA) at Fort Detrick, MD. This is a contingent position pending award of a federal GSA MAS task order with a target start date of August 1, 2026.
The Regulatory Affairs Scientist provides regulatory strategy, submission preparation, and FDA interaction support across the ORA product portfolio. This role prepares and manages content for INDs, IDEs, NDAs, BLAs, 510(k)s, PMAs, and pre-submissions, coordinates FDA meetings and correspondence, and ensures regulatory compliance across the full product lifecycle. The Regulatory Affairs Scientist works closely with the Senior Regulatory Affairs Scientist and cross-functional program teams to advance DoD medical products through FDA review and approval.
Responsibilities
- Prepare regulatory strategy documents, submission plans, and regulatory intelligence assessments to support DoD medical product development
- Author and coordinate content for FDA submissions including INDs, IND amendments, NDAs, supplemental NDAs, BLAs, sBLAs, ANDAs, 505(b)(2) applications, IDEs, 510(k)s, PMAs, De Novo requests, and pre-submissions (Q-Sub/Type A/B/C/D meetings)
- Manage FDA correspondence and meeting logistics including preparation of meeting requests, briefing documents, meeting minutes, and post-meeting follow-up
- Maintain regulatory content within Regulatory Information Management (RIM) systems, eCTD repositories, and structured submission tracking databases
- Review clinical protocols, informed consent forms, Investigator Brochures, clinical study reports, and product labeling for regulatory compliance
- Support inspection readiness activities including FDA BIMO inspections, PAI inspections, and post-approval inspections
- Coordinate with cross-functional teams including CMC, Clinical, Nonclinical, and Pharmacovigilance to align regulatory strategy with program objectives
- Perform regulatory intelligence monitoring on FDA guidance documents, ICH updates, and international regulatory developments; assess impact on program strategy
- Support post-marketing regulatory activities including annual reports, PADERs, PBRERs, safety reporting, and labeling supplements
- Contribute to responses to FDA information requests, clinical hold responses, and complete response letters
- Support development of SOPs, work instructions, and regulatory templates as needed
Required Qualifications
- Bachelor's degree in life sciences, pharmacy, chemistry, biology, biomedical engineering, or a related scientific discipline required
- Minimum 4 years of regulatory affairs experience in the pharmaceutical, biotechnology, or medical device industry
- Demonstrated hands-on experience contributing to at least one major FDA submission (IND, NDA, BLA, 510(k), PMA, or equivalent)
- Working knowledge of 21 CFR Parts 11, 50, 54, 56, 210, 211, 312, 314, 600, 610, 803, 806, 807, 812, 814, and 820 as applicable to product type
- Familiarity with eCTD format, module structure, and FDA electronic submissions
- Strong scientific writing skills; ability to translate technical content into regulatory-quality documents
- Excellent organizational, project management, and communication skills
- U.S. citizenship required; ability to obtain and maintain a T1/HSPD-12 Public Trust investigation
Preferred Qualifications
- Regulatory Affairs Certification (RAC) from RAPS, or Master's in Regulatory Affairs (MSRA)
- Prior experience supporting DoD, DHA, USAMRDC, BARDA, or other federal medical product development programs (Joint Vaccine Acquisition Program, Chemical/Biological Defense, medical countermeasures)
- Therapeutic-area depth in vaccines, infectious diseases, oncology, medical countermeasures, or combination products
- Experience with international regulatory submissions (EMA, PMDA, Health Canada)
- Master's, PhD, or PharmD in a scientific discipline
- Experience with combination product regulatory strategy under 21 CFR Part 3 and Part 4
Pay: $85,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
