Regulatory Strategist Program Manager

Key Responsibilities

• Support investigators in the development and implementation of a regulatory strategy to help support their locally held IND/IDE studies
• Aid in the education and mentorship for faculty to help them understand regulatory needs and limitations
• Present to funding agencies and campus leadership on the proposed and selected regulatory strategy
• Maintain a thorough understanding of regulatory requirements and early phase drug development and proactively identify potential challenges
• Interpret and apply regulatory requirements in a practical and strategic manner.
• Develop and implement regulatory strategy processes consistent with departmental strategies for large scales, multi-stakeholder projects such as ARPA-H initiatives.
• Review grant and funding proposals to determine if external consulting or subcontracts are needed in order to achieve the desired goals of the grant/contract
• Identify and engage with the appropriate 3rd party consulting, if deemed necessary
• Manage the vendor relationship with consultants and ensure that all work is appropriately delegated and adequate oversight is provided
• Timely identification of issues with contractors, including need to end arrangements if consultants are not meeting contractual obligations

Regulatory Specialist Responsibilities

• Serves as the primary point of contact for other internal/external contributors to the FDA submissions
• This includes direct communications and meetings about the project with regulatory compliance, scientific review committees, the manufacturing sites, the hospital-based research administration, and other entities on campus as needed
• Serves as the primary point of contact with external entities, such as outside suppliers of materials, and FDA
• Assists in CMC dossier preparation and/or technical manufacturing sections for investigator held INDs and/or IDEs
• Maintains version control for documentation throughout the IND/IDE’s life cycle
• Identifies and elevates barriers delaying any FDA submissions, assists with identifying solutions
• Ensures currency and completeness of Trial Master Files for projects under IND/IDE Office oversight
• Assists in developing and providing Standard Operating Procedures, educational resources and training for IND/IDE Office team members and investigators and their research teams

Qualifications

• Bachelor's degree from an accredited institution
• Minimum of 4-6 years of professional experience in analytical development, early phase drug development, and regulatory strategy
• Preferred: 7+ years of professional experience in analytical development, early phase drug development, and regulatory strategy
• 5+ years of experience in regulatory affairs within the healthcare industry
• Direct experience with IND and/or IDE submissions to FDA, specifically CBER and CDRH, including but not limited to: exemption determinations, requests for determination, as well as preparation for FDA INTERACT, pre-IND, and/or q-submission meetings
• Previous experience with the creation of CMC sections and other content supporting IND/IDE submissions