Director, Regulatory Submissions & RIMS

AgFunder Inc.; Northern (KY); Hybrid; USD 155,000 - 220,000; Full time

Benefits offered by this job

100% remote work

Health, dental, and vision insurance

401k plan

Job summary

Faeth is seeking an Associate Director, Regulatory Operations to own the regulatory submissions backbone for FDA and ex-US authorities. The role oversees planning, publishing, and dispatch, with RIMS administration and archival integrity at the core.

The successful candidate will drive submission readiness, coordinate with CROs, and lead process improvements while potentially expanding into submission strategy and regulatory intelligence.

Qualifications

• Bachelor's degree in life sciences or related field; 8+ years in regulatory operations with ownership of submissions.
• Deep, hands-on knowledge of eCTD structure, lifecycle management, and validation across US and ex-US regions.
• Experience preparing INDs/CTAs and working with CROs/partners on regulatory submissions.
• Proficiency with electronic publishing tools and with electronic gateways and regional portals.
• Ownership or administration of a RIMS platform including data integrity, reporting, and system release/UAT.
• Understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, and records retention requirements.
• Vendor management experience including scoping, oversight, and performance accountability.
• Strong document formatting skills (MS Word, PDF) and ability to diagnose publishing issues.

Responsibilities

• Lead end-to-end planning, publishing, and dispatch of regulatory submissions (INDs, CTAs, DSURs, etc.).
• Manage submission-level project plans, timelines, and risk escalation with options.
• Oversee RIMS administration, data integrity, and dashboards for stakeholders.
• Maintain archival practices, inspection readiness, and cross-functional collaboration.
• Coordinate with CROs and vendors on deliverables, timelines, and quality.
• Drive process improvements and use AI/tools to enhance efficiency.

Skills

Regulatory operations

Submission management

eCTD knowledge

RIMS administration

Vendor management

AI in regulatory

Education

Bachelor's degree in life sciences

Tools

MS Word

Adobe Acrobat

Electronic publishing tools

Job description

Faeth is seeking an Associate Director, Regulatory Operations to own the regulatory submissions backbone for FDA and ex-US authorities. The role oversees planning, publishing, and dispatch, with RIMS administration and archival integrity at the core.

The successful candidate will drive submission readiness, coordinate with CROs, and lead process improvements while potentially expanding into submission strategy and regulatory intelligence.