Senior Regulatory Affairs Scientist

Job Description

Job Description

Senior Regulatory Affairs Scientist — 2 Openings

EMD Strategies | Office of Regulatory Affairs (ORA) | Fort Detrick, Frederick, MD | Hybrid

EMD Strategies is hiring two Senior Regulatory Affairs Scientists to support the Office of Regulatory Affairs (ORA) at Fort Detrick, Maryland. ORA provides regulatory and clinical support across the full life cycle of FDA-regulated medical products sponsored by the Department of Defense. You will work alongside government scientists, clinicians, and regulatory professionals under the DHA Research and Development / USAMRDC enterprise.

Both positions are open and actively hiring.

TWO POSITIONS, TWO FOCUS AREAS

The two seats share the same core scope and seniority. They are differentiated by portfolio:

Track 1 — Drug & Biologics (CDER / CBER)

Track 2 — Special Programs (Emergency Use / Medical Countermeasures)

Apply once. Indicate in your cover note or application message which track fits your background, or note if you have depth in both. Focus-area requirements are listed separately below.

ABOUT THE ROLE

In either track you will serve as the senior regulatory subject matter expert for assigned DoD-sponsored products, acting as primary FDA contact while developing the regulatory staff around you. The role combines hands-on submission work with team leadership and process improvement.

WHAT YOU WILL DO (BOTH TRACKS)

- Serve as primary FDA contact for assigned products, reviewing, analyzing, and responding to agency communications by regulatory deadlines

- Lead development of written regulatory strategies describing the pathway to approval, licensure, or clearance

- Create and maintain Target Product Profiles

- Train and develop regulatory staff, manage workloads, and align work to program objectives

- Monitor emerging U.S. and global regulations and advise leadership on impact

- Lead working groups for process improvement, regulatory intelligence, and quality review

- Identify and mitigate regulatory risk through a project Risk Register

- Coordinate, prepare, review, and archive regulatory submission documents in EDMS

- Participate as regulatory subject matter expert in site visits at industry partner manufacturing facilities

- Write, review, and revise SOPs; maintain ClinicalTrials.gov registrations

WHAT YOU NEED (BOTH TRACKS)

- 10 to 15 years in regulatory affairs supporting FDA-regulated product development

- Bachelor's, Master's, or PhD in a life science or related discipline

- Direct experience as an FDA point of contact, including meeting requests and responses

- Experience leading regulatory strategy for at least one product through a major milestone

- Working knowledge of 21 CFR 312 and 21 CFR 812

- Demonstrated experience mentoring or supervising regulatory staff

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TRACK 1 — DRUG & BIOLOGICS (CDER / CBER)

Portfolio spans small molecules, vaccines, therapeutic proteins, blood products, and cell and gene therapies.

Additional responsibilities:

- Own the IND lifecycle end to end: pre-IND packages, original INDs, protocol and information amendments, IND safety reports, and annual reports or DSURs

- Lead marketing application strategy and preparation for NDA, BLA, and supplemental submissions, including content planning across eCTD Modules 1 through 5

- Prepare for and lead formal FDA milestone meetings (pre-IND, Type A, Type B, Type C, End-of-Phase 2, pre-NDA and pre-BLA), including briefing packages and reconciliation of meeting minutes

- Advise on expedited development pathways including Fast Track, Breakthrough Therapy, RMAT, Priority Review, Accelerated Approval, and orphan drug designation

- Provide regulatory input to CMC development, comparability, stability, and lot release strategy

Additional requirements:

- A substantial majority of your experience concentrated in drugs and/or biologics regulated under 21 CFR 312, 21 CFR 314, and 21 CFR 600–601

- Ownership of at least one IND from pre-IND through active clinical development

- Contribution to at least one NDA, BLA, or major supplement

- Documented experience leading formal FDA milestone meetings with CDER or CBER

- Working knowledge of ICH E6, M4 (CTD), and the ICH Q series as applied to drug and biologic submissions

Nice to have for this track:

- Vaccine or advanced therapy (cell, gene, tissue) regulatory experience

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TRACK 2 — SPECIAL PROGRAMS (EMERGENCY USE / MEDICAL COUNTERMEASURES)

Portfolio covers medical countermeasures, emergency use pathways, and products advanced under public health emergency and force health protection authorities — CBRN, pandemic, and infectious disease threat programs.

Additional responsibilities:

- Develop and maintain pre-EUA packages and prepare Emergency Use Authorization requests under Section 564 of the FD&C Act, including amendments, reissuances, and planning the transition from EUA to full licensure or approval

- Advise on Animal Rule development pathways (21 CFR 314 Subpart I and 21 CFR 601 Subpart H) for products where human efficacy studies are neither ethical nor feasible

- Support expanded access and emergency use IND submissions, including individual patient, intermediate-size, and treatment protocols under 21 CFR 312

- Advise program leadership on DoD-specific frameworks governing investigational product use for force health protection, including DoDI 6200.02 and related Title 10 authorities

- Coordinate regulatory strategy with interagency and industry partners including ASPR/BARDA, JPEO-CBRND, CDC, and NIH

- Operate regulatory workstreams under surge timelines, including outbreak response, contingency taskings, and rapid FDA engagement

Additional requirements:

- Hands-on regulatory experience on at least one emergency use or public health emergency program — for example an EUA or pre-EUA package, an emergency use IND, an expanded access program, or a COVID-19 or comparable outbreak-response product

- Working knowledge of Section 564 EUA authority and the pre-EUA process, including the evidentiary standards FDA applies

- Demonstrated ability to execute regulatory deliverables under compressed timelines in a surge or crisis-response environment

- Familiarity with the medical countermeasure enterprise and with government sponsor and interagency partner coordination

Nice to have for this track:

- Animal Rule product development experience

- Familiarity with the PREP Act, material threat medical countermeasure priority review vouchers, or BioShield-funded programs

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NICE TO HAVE (BOTH TRACKS)

- Regulatory Affairs Certification (RAC)

- Experience across drugs, biologics, and devices

- Prior DoD, USAMRDC, BARDA, or ASPR support experience

TOOLS AND SYSTEMS

eCTD publishing tools, EDMS, ClinicalTrials.gov, Risk Registers, SharePoint, Microsoft Office Suite

LOCATION AND ELIGIBILITY

- Based at Fort Detrick, Frederick, Maryland. Hybrid schedule — a portion of the work week on site at the Government facility and a portion at an approved alternate worksite. Telework is authorized at the convenience of the Government on a case-by-case basis, coordinated through the Contractor Task Manager and approved by the Contracting Officer's Representative, and is reviewed quarterly. Candidates must be able to work on site at Fort Detrick as required.

- Core business hours are Monday through Friday, 0900–1600 Eastern Time. Typically 8 hours per day, 80 hours per two-week period.

- U.S. citizenship required.

- Must be able to obtain and maintain a favorably adjudicated T1 / HSPD-12 credentialing determination prior to start. Investigation cost is covered by the Government.

COMPENSATION AND BENEFITS

Salary range: $140,000 – $155,000. Final offer is determined by experience, education, and contract labor category placement.

Benefits include:

- Medical and prescription coverage

- Dental coverage

- Vision coverage

- 401(k) with employer match

- Paid time off and 11 paid federal holidays

- Life insurance and Accidental Death & Dismemberment

- Short-Term and Long-Term Disability

- Voluntary life, critical illness, accident, and hospital indemnity coverage

A full benefits overview will be provided separately during the hiring process.

EMD Strategies is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.