Senior DoD Regulatory Affairs SME – Drugs & Devices

Arcetyp LLC; Frederick (MD); On-site; USD 130,000 - 190,000; Full time

Job summary

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME to lead regulatory strategy for drugs, biologics, blood products, and medical devices, onsite at Fort Detrick, MD.

You will develop submission plans, prepare INDs/NDAs/PMAs/510(k)s, and advise cross-functional teams on regulatory risks and lifecycle strategies while mentoring colleagues, with a focus on DHA/DoD program requirements.

Qualifications

• Senior FDA regulatory affairs expertise.
• Experience with drugs, biologics, blood products or medical devices.
• Knowledge of product development lifecycle.
• Experience with regulatory submissions and agency interactions.
• Clinical and preclinical development exposure.

Responsibilities

• Serve as senior regulatory SME for military-relevant drugs, biologics, blood products, medical devices.
• 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 on regulatory risks, opportunities and lifecycle strategy.
• Mentor teams on regulatory requirements and best practices.

Skills

FDA regulatory affairs

Drugs/biologics/medical devices

Regulatory submissions

Lifecycle management

Cross-functional collaboration

Job description

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME to lead regulatory strategy for drugs, biologics, blood products, and medical devices, onsite at Fort Detrick, MD.

You will develop submission plans, prepare INDs/NDAs/PMAs/510(k)s, and advise cross-functional teams on regulatory risks and lifecycle strategies while mentoring colleagues, with a focus on DHA/DoD program requirements.