Regulatory Affairs Lead, IND/IDE

Job Title: Regulatory Affairs Lead, IND/IDE
Location: Remote
Schedule: Standard business hours and M-F
Type: 12-month Contract to Hire
Hourly rate: $45-$60

Overview:
Our client is seeking a Regulatory Affairs Lead, IND/IDE. This senior position provides end-to-end regulatory strategy and hands-on authorship for FDA-regulated investigator-initiated research, including original IND/IDE submissions, amendments, safety reporting, and FDA meetings. The role partners closely with investigators and cross-functional teams to streamline start-up through close-out, build SOPs/templates, and ensure inspection-ready compliance. Candidates with international regulatory experience are strongly encouraged to apply !

Responsibilities:

• Advise investigators on regulatory pathway, product classification (drug/biologic/device/SaMD/combination), and study design considerations aligned with ICH and FDA guidance.
• Lead FDA engagement (pre-IND/Type B/Type C/Q-Sub), including briefing packages, meeting management, and follow-ups.
• Author and own original and maintenance submissions under 21 CFR 312/812 (INDs/IDEs), including amendments, annual/progress reports, IDE supplements, and safety/UADE reporting.
• Coordinate IRB alignment (including reliance/SMART IRB) and integrate regulatory workflows with institutional systems (e.g., CTMS/OnCore, eReg) and ClinicalTrials.gov registration/results.
• Establish and maintain SOPs, templates, and training programs; mentor regulatory staff and support grant development/JIT responses.

Requirements

• Advanced degree in a relevant field or equivalent experience.
• Minimum eight years of progressive regulatory affairs experience with documented success leading original IND and/or IDE submissions and FDA meetings.
• Deep knowledge of 21 CFR 312/812 and related parts (50, 56, 11), ICH-GCP (E6/E8), and familiarity with device quality systems (QSR/QMSR) and ISO 13485; working knowledge of SaMD expectations.
• Exceptional technical writing, project management, and cross-functional communication skills.
• Experience within an academic medical center or equivalent complex research environment.

Preferred Qualifications:

• International regulatory exposure.
• Familiarity with eCTD publishing workflows/tools, ClinicalTrials.gov results reporting, CTMS (OnCore), and eReg systems.
• Prior leadership in audit/inspection management and team mentoring

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.