DoD Regulatory Affairs Lead: Drugs, Biologics & Devices

Arcetyp LLC; Gaithersburg (MD); Remote; USD 120,000 - 190,000; Full time

Job summary

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices for an onsite role in Fort Detrick, MD. You will lead regulatory strategies, submissions, and agency interactions to support military, DoD, and commercial programs.

Responsibilities include preparing INDs/NDAs/PMAs/510(k)s, reviewing technical files, and advising product teams on lifecycle regulatory considerations.

Qualifications

• Senior FDA regulatory affairs expertise.
• Drugs, biologics, blood/blood products and/or medical devices.
• Product development lifecycle.
• Regulatory submissions and agency interactions.
• Clinical and preclinical development.
• Cross-functional work with R&D, manufacturing, clinical and product management.

Responsibilities

• Serve as senior regulatory SME supporting military-relevant drugs, biologics, blood products, medical devices and other medical solutions.
• Develop and review regulatory strategies and submission plans.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting packages, audit reports and inspection products.
• Support interactions with FDA/regulatory agencies and sponsors.
• Advise product managers/IPTs on regulatory risks, opportunities and lifecycle strategy.
• Mentor teams on regulatory requirements and best practices.

Skills

FDA regulatory affairs

Drugs/biologics/medical devices

Product development lifecycle

Regulatory submissions

Clinical development

Cross-functional collaboration

Job description

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices for an onsite role in Fort Detrick, MD. You will lead regulatory strategies, submissions, and agency interactions to support military, DoD, and commercial programs.

Responsibilities include preparing INDs/NDAs/PMAs/510(k)s, reviewing technical files, and advising product teams on lifecycle regulatory considerations.