We are seeking an Associate Director, Regulatory Operations to own the operational backbone of our global regulatory filings. This is a hands-on, high-ownership role responsible for the planning, and manage publishing, and delivery of submissions to FDA and ex-US health authorities with CROs,, for the administration and data integrity of our Regulatory Information Management System (RIMS), for our submission archive and inspection readiness posture
The role is deliberately scoped to grow. As our pipeline advances within the clinical development stages ultimately towards registration, the person in this seat will have the opportunity to move beyond execution into submission strategy, regulatory intelligence, and functional leadership - shaping how the regulatory organization operates rather than only running it.
Reports to: VP, Regulatory Affairs
Location: Remote (U.S.)
Responsibilities:
Submission Management & Publishing (US and ex-US)
* Lead end-to-end planning, compilation, publishing, validation, and dispatch of regulatory submissions, including INDs, CTAs, amendments, annual reports/DSURs, briefing packages, meeting requests, orphan drug and expedited-pathway applications, and future MAA/NDA/BLA content.
* Own submission-level project plans: content collection timelines, document readiness tracking, publishing windows, QC cycles, and dispatch dates. Escalate risks early with options, not just status.
* Apply working knowledge of regional requirements across jurisdictions - FDA eCTD Module 1, EU CTR/CTIS, UK MHRA, Health Canada, and APAC/ROW as the portfolio requires - and translate those differences into actionable guidance for authors and study teams.
* Manage electronic dispatch and gateway operations (FDA ESG/Gateway, WebTrader, CESP, CTIS, regional portals), including account administration, certificates, test submissions, and troubleshooting failed transmissions.
* Perform and oversee technical and publishing QC: hyperlinks, bookmarks, granularity, lifecycle operations, PDF rendering, validation criteria, and eCTD backbone integrity.
Own resolution of validation errors before dispatch.
* Maintain submission readiness for evolving standards (eCTD v4.0, structured content, regional electronic application form requirements) and lead the organization's preparedness work.
RIMS Ownership & Systems
* Serve as business owner and day-to-day administrator of the RIMS platform including configuration requests, user access and training, controlled vocabularies, and document/record lifecycles.
* Maintain the integrity and completeness of registration, submission, correspondence, and health-authority commitment data so that the system is a trusted source of truth for reporting and inspection.
* Lead system enhancements, migrations, and releases: requirements gathering, vendor coordination in line with 21 CFR Part 11, EU Annex 11, and internal computer system validation procedures.
* Build and maintain dashboards, metrics, and trackers that give Regulatory, Clinical Development, and Program Management visibility into submission status, commitments, and cycle times.
* Develop and maintain SOPs, work instructions, style guides, templates, and document-formatting standards; train authors and study teams on their use.
Archival, Records & Inspection Readiness
* Own the regulatory archive: official submission-ready copies, health-authority correspondence and meeting minutes, approvals, and licensing documentation, with defined retention periods and retrieval procedures.
* Ensure archival practices satisfy GxP requirements and are defensible in an FDA or EU inspection or partner audit; support inspection preparation, requests, and responses.
* Establish and maintain reconciliation processes between the archive, RIMS, the eTMF, and CRO-held records so that ownership of records is unambiguous at study close-out.
CRO & Vendor Partnership
* Act as the primary regulatory operations point of contact for CROs supporting IND and CTA submissions: define deliverables and formats, align on timelines, review incoming documents for submission readiness, and drive issue resolution.
* Manage publishing and regulatory operations vendors - scope of work, SLAs, budgets and accruals, capacity planning, quality oversight, and performance reviews. Hold vendors accountable to agreed quality and turnaround standards.
* Coordinate with local affiliates, regulatory consultants, and legal representatives in ex-US markets to secure country-specific documents (legalized/notarized documents, GMP certificates, IB translations, labeling) on the critical path.
* Partner cross-functionally with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing to secure submission content on schedule and to the right standard.
Process, Compliance & Strategic Contribution
* Continuously improve regulatory operations processes, identifying where automation, templates, or better upstream discipline reduce cycle time and rework.
* Provide regulatory operations input into program planning and submission strategy discussions, including feasibility, sequencing, and resourcing implications of proposed filing plans.
* Contribute to regulatory intelligence monitoring for operational and electronic-standards changes, and advise leadership on impact and required action.
* Mentor junior staff and contractors; as the function grows, take on direct people management.
Requirements:
* Bachelor's degree in a life science, information science, or related field.
8+ years of regulatory operations experience in biotech, pharmaceutical, or CRO/vendor environments, including demonstrated ownership of submissions from planning through dispatch.
* Deep, hands-on knowledge of eCTD structure, lifecycle management, and validation, with practical experience across US and at least one ex-US region.
* Direct experience preparing and submitting INDs and/or CTAs, including work with CROs or partners on clinical trial applications.
* Working proficiency with electronic publishing tools and with electronic gateways and regional portals.
* Demonstrated ownership or administration of a RIMS platform, including data integrity, reporting, and system release/UAT activities.
* Practical understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation standards, and records retention and archival requirements.
* Vendor management experience: scoping, oversight, quality management, and performance accountability.
* Advanced document formatting and template skills (MS Word, Adobe Acrobat) and comfort diagnosing technical publishing issues without escalating first.
* Communicates clearly and effectively across functions and levels, tailoring messaging to the audience and keeping key stakeholders informed.
* Builds strong cross-functional relationships and works effectively with internal teams, external partners, and vendors to achieve shared goals.
* Proactively identifies challenges and develops practical, thoughtful solutions rather than waiting for direction.
* Curious and proactive about leveraging AI and emerging technologies to improve efficiency, streamline workflows, and enhance the quality of work.
Nice to have:
* Oncology experience - regulatory operations support for oncology programs, including the operational demands of expedited pathways (Fast Track, Breakthrough Therapy, RMAT, PRIME), adaptive or basket/umbrella trial designs, frequent protocol amendments, and parallel multi-region CTA submissions. Familiarity with Project Orbis and oncology-specific data expectations is a plus.
* Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role.
* RIM administration or configuration experience; eCTD v4.0 readiness work.
* Experience in a small or mid-sized company where regulatory operations is a lean function and processes must be built rather than inherited.
* Experience supporting health-authority inspections or partner audits.
RAC certification or equivalent.
Compensation Range: $155,000 - $220,000 (actual compensation may vary based on experience, qualifications and location)
Benefits:
* Competitive salary and equity in a well-funded, clinical-stage biotech
* 100% remote work and flexible schedule
* Health, dental, and vision for you and your dependents
* Flexible time off
* Generous parental leave
* Traditional and Roth 401k
* Mission oriented, remote first culture
