[Remote] Head of Regulatory Operations and Submission Management

Note: The job is a remote job and is open to candidates in USA. reputed company is a gene therapy company focused on delivering life-changing treatments for patients with urgent unmet medical needs. The Head of Regulatory Operations and Submission Management will provide strategic and operational leadership for global regulatory operations, submission management, systems, and execution across the product portfolio, while leading the Regulatory Operations organization and ensuring submission quality, compliance, and timeliness.

Responsibilities

Establish and lead the Regulatory Operations strategy and execution to deliver compliant, high‑quality global submissions and maintain submission/registration archives across the product lifecycle (development through post‑approval)Build, develop, and manage a Regulatory Operations organization (direct reports, vendors and/or matrix resources), including capability building, training and performance managementOversee submission planning, tracking, publishing, compilation, QC, dispatch, and archiving for major submission types (e.g., INDs/CTAs, NDAs/BLAs/MAAs, amendments/supplements/variations, annual reports, and other lifecycle submissions), ensuring adherence to reputed company authority technical requirements and timelinesServe as the operational submission execution partner to Regulatory Strategy and Regulatory CMC leads and cross‑functional reputed company reputed company experts, translating regulatory milestones into feasible operational plans, resourcing models, and publishing schedules while proactively identifying risks and mitigation strategiesEstablish and lead Regulatory Operations process excellence, including creating/maintaining SOPs, work instructions, templates, style guides, and best practices for document readiness, publishing, archival, and controlled submission recordsEstablish and manage quality systems for Regulatory Operations, including technical QC standards (formatting, hyperlinks/bookmarks, PDF requirements, metadata), submission readiness checks, error prevention, corrective actions, and continuous improvement initiativesLead Regulatory Information Management (RIM) and publishing systems governance, acting as business owner for tools supporting submission planning/content management/publishing/archival and regulatory data integrity; partner with IT and Quality on validation, access controls, audit trails, reputed company control, and vendor-reputed company where applicableOversee and manage external vendors/outsourcing reputed company (publishing, system providers, ancillary submission services) including scope definition, budgets, performance monitoring, and issue resolutionEnsure inspection readiness for Regulatory Operations processes, regulated systems, and submission archives; support audits/inspections by preparing evidence packages, demonstrating system/process controls, and coordinating responses and CAPAs in partnership with QualityMaintain regulatory operations intelligence regarding evolving global electronic submission standards and operational requirements (e.g., agency technical specifications, lifecycle management expectations), and lead reputed company implementation to keep the organization compliant and currentPartner cross-functionally with Regulatory Affairs Strategy, Medical Writing, CMC/Technical Operations, Quality, Biometrics, Clinical Operations, IT and Project Management to embed operational excellence and predictable submission execution into integrated development plans Skills

Bachelor's degree required15+ years of progressive experience in Regulatory Operations and global submission management/publishing within pharmaceutical and/or biotechnology organizations, including leadership responsibilityDemonstrated experience leading end‑to‑end submission execution (planning, publishing, QC, dispatch, archival) for U.S. and ex‑U.S. submissions, with strong knowledge of global submission formats and technical standards (eCTD/CTD/ACTD, as applicable)Proven experience serving as business owner and implementing/optimizing regulatory systems (e.g., RIM/publishing/content management), including data governance and user adoptionExperience establishing SOPs/standards and driving operational and quality process improvements in a regulated environmentExperience managing vendors/outsourcing reputed company and developing scalable operating models (insourcing/outsourcing mix) across different stages of company growthIn-depth, working, knowledge and understanding of FDA, EMA and ICH regulations and guidelines governing electronic submission standardsExpert knowledge of electronic submission reputed company and technical QC expectations (e.g., document formatting standards, hyperlinking/bookmarking, PDF technical requirements, met

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