Associate Director/Director, Regulatory Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of the operational framework for global regulatory submissions and report directly to the VP of Regulatory Affairs.

• Oversee the comprehensive planning, compilation, publishing, validation, and submission of INDs, CTAs, amendments, annual reports/DSURs, briefing packages, meeting requests, orphan-drug and expedited-pathway applications, as well as future MAA/NDA/BLA content.

• Manage project plans at the submission level, including content collection timelines, document readiness tracking, publishing schedules, QC cycles, and dispatch dates; proactively escalate risks with suggested solutions.

• Implement regional requirements for FDA eCTD Module 1, EU CTR/CTIS, UK MHRA, Health Canada, and jurisdictions across APAC/ROW.

• Oversee electronic dispatch and gateway operations, including FDA ESG/Gateway, WebTrader, CESP, CTIS, and regional portals.

• Conduct and supervise technical and publishing quality control, focusing on hyperlinks, bookmarks, granularity, lifecycle operations, PDF rendering, validation criteria, and the integrity of the eCTD backbone.

• Maintain preparedness for eCTD v4.0, structured content, and regional electronic application form requirements.

• Act as the business owner and daily administrator of the RIMS platform.

• Ensure the integrity of registration, submission, correspondence, and health authority commitment data.

• Lead system enhancements, migrations, and releases, which include gathering requirements, coordinating with vendors, and ensuring compliance with validation.

• Create dashboards, metrics, and trackers that monitor submission status, commitments, and cycle times.

• Develop and uphold SOPs, work instructions, style guides, templates, and document formatting standards; provide training for authors and study teams.

• Manage the regulatory archive, ensuring submissions, correspondence, approvals, and licensing documentation are retained and readily accessible for inspections.

• Establish reconciliation processes among the archive, RIMS, eTMF, and records held by CROs.

• Serve as the main regulatory operations contact for CROs; define deliverables, align timelines, review documents, and address issues.

• Manage publishing and regulatory operations vendors, including scopes, SLAs, budgets, quality oversight, and performance evaluations.

• Collaborate with affiliates, consultants, and legal representatives to obtain country-specific documents for ex-US submissions.

• Partner with Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, and Medical Writing teams.

• Consistently seek process improvements through automation, templates, and proactive discipline.

• Contribute regulatory operations insights to program planning, submission strategy, regulatory intelligence, and monitoring of operational/electronic standards.

• Mentor junior staff and contractors, with the potential for direct people management as the function expands.

⛳️ Requirements

• Bachelor's degree in a life science, information science, or a related field.

• Over 8 years of regulatory operations experience within biotech, pharmaceutical, or CRO/vendor environments, demonstrating ownership of submissions from planning to dispatch.

• In-depth, hands-on knowledge of eCTD structure, lifecycle management, and validation, with practical experience in the US and at least one other region outside the US.

• Direct experience in preparing and submitting INDs and/or CTAs, including collaboration with CROs or partners on clinical trial applications.

• Proficient in using electronic publishing tools as well as electronic gateways and regional portals.

• Proven experience in owning or administering a RIMS platform, ensuring data integrity, reporting, and system release/UAT activities.

• Solid understanding of 21 CFR Part 11, EU Annex 11, ICH guidelines, GxP documentation standards, as well as records retention and archival requirements.

• Experience in vendor management, including scoping, oversight, quality management, and accountability for performance.

• Advanced skills in document formatting and templates (MS Word, Adobe Acrobat), with the ability to diagnose technical publishing issues independently.

• Excellent communication skills, clearly conveying information across functions and levels, tailoring messages to the audience while keeping key stakeholders informed.

• Ability to build strong cross-functional relationships and work collaboratively with internal teams, external partners, and vendors to achieve common objectives.

• Proactively identify challenges and develop practical, thoughtful solutions rather than waiting for direction.

• Demonstrate curiosity and proactivity in leveraging AI and emerging technologies to enhance efficiency, streamline workflows, and improve work quality.

• A background check and verification of eligibility to work in the United States is required.

• Preferred: experience in oncology; experience in supporting or preparing an NDA/BLA/MAA or major amendment; RIM administration/configuration; readiness for eCTD v4.0; experience in small or mid-sized companies; health authority inspection or partner audit experience; RAC certification or equivalent.

🏝️ Benefits

• Competitive salary and equity in a well-funded, clinical-stage biotech.

• 100% remote work with a flexible schedule.

• Health, dental, and vision coverage for you and your dependents.

• Flexible time off policy.

• Generous parental leave.

• Traditional and Roth 401k options.

• A mission-oriented, remote-first culture.