Location: Frederick, MD

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Description:

We are seeking qualified candidates for Subject Matter Expertise support in the area of Regulatory Compliance with the Food and Drug Administration (FDA).  This position is based in Ft. Detrick – Frederick, Maryland, and will support the Department of the Army.   Ideally the individual will start in March 2020.  US Citizenship with the ability to obtain a DOD Clearance.

 

Primary Responsibilities:

The SME will focus on ensuring products in development follow the FDA Regulatory Guidelines and will be responsible in following areas:

 

• Provide support to product development efforts focused on regulatory compliance and risk mitigation aspects for various product development efforts of maturity that spans from early clinical (phase 1) to late clinical development (phase 3) and beyond. This work directly supports medical product development for the Project Manager (PjM), Deputy PM, and PdMs duties for a variety of combat casualty care and infectious disease programs. 

• Provide expert written reviews, briefings, and recommendations to Product Managers for developmental medical products to include reviewing and interpreting results with an emphasis toward compliance with FDA requirements.  

• Review deliverables from outside Sponsors (comment on FDA communications/ packages, any regulatory deliverables, etc.).  

• Assist with developing sound regulatory strategy for products, including blood products.  This includes Target Product Profiles and the regulatory strategy to match.

• Be a substantive participant in IPTs and provide input regarding technical and compliance of biopharmaceuticals (including blood products) and risk management/mitigation. 

• Advise the PdMs and PjM in regard to issues involving regulatory compliance and risk

• Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills. 

• Manage numerous efforts and effectively prioritize and multi-task requirements that have a direct impact on the Program.

• Attend and participate in site visits, provide product support in IPT meetings and briefings, etc.

 

Education:

• Bachelor’s Degree in a related field, Master’s preferred.  

 

Qualifications:

• 10+ years of related experience in regulatory compliance.

• Regulatory Affairs Certification (RAC), required.

• Experience with all divisions of the FDA, preferred.

• Experience with blood products, preferred.

• Public Trust required.