Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices

Essential Job Functions:

• 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.

Necessary Skills and Knowledge:

• 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.

Minimum 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.

Preferred Qualifications:

• Current WPAC Regulatory Affairs incumbent(s) highest-priority incumbent capture target.
• Direct experience preparing IND/NDA/PMA/510(k) submissions.
• FDA meeting and regulatory agency interaction experience.
• Blood/biologics/combat casualty care regulatory experience.
• DHA/DoD medical acquisition experience.
• RAC or comparable regulatory certification.