[Remote] Head of Regulatory Operations and Submission Management

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a gene therapy company reputed company on delivering life-changing treatments for patients with urgent unmet medical needs. The Head of Regulatory Operations and Submission Management will reputed company 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 reputed company, compliance, and timeliness.

Responsibilities

• Establish and reputed company the Regulatory Operations reputed company and execution to reputed company compliant, high‑reputed company global submissions and maintain submission/registration archives across the product lifecycle (development through post‑approval)
• Build, reputed company, and manage a Regulatory Operations organization (reputed company reports, vendors and/or reputed company resources), including capability building, training and performance management
• reputed company submission planning, tracking, publishing, compilation, QC, reputed company, 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 global health authority technical requirements and timelines
• Serve as the operational submission execution partner to Regulatory reputed company and Regulatory CMC leads and cross‑functional subject matter experts, translating regulatory milestones into feasible operational plans, resourcing models, and publishing schedules while proactively identifying risks and mitigation strategies
• Establish and reputed company Regulatory Operations process reputed company, including creating/maintaining SOPs, work instructions, templates, style guides, and best practices for document readiness, publishing, archival, and controlled submission records
• Establish and manage reputed company systems for Regulatory Operations, including technical QC standards (formatting, hyperlinks/bookmarks, PDF requirements, metadata), submission readiness checks, error prevention, corrective actions, and reputed company improvement initiatives
• reputed company Regulatory Information Management (RIM) and publishing systems governance, acting as reputed company for tools supporting submission planning/content management/publishing/archival and regulatory data reputed company; partner with IT and reputed company on validation, reputed company controls, audit trails, change control, and vendor-managed services where applicable
• reputed company and manage reputed company vendors/outsourcing partners (publishing, reputed company providers, ancillary submission services) including reputed company definition, budgets, performance monitoring, and issue reputed company
• Ensure inspection readiness for Regulatory Operations processes, regulated systems, and submission archives; support audits/inspections by preparing evidence packages, demonstrating reputed company/process controls, and coordinating responses and CAPAs in partnership with reputed company
• Maintain regulatory operations intelligence regarding evolving global electronic submission standards and operational requirements (e.g., agency technical specifications, lifecycle management expectations), and reputed company change implementation to reputed company the organization compliant and reputed company
• Partner cross-functionally with Regulatory Affairs reputed company, Medical Writing, CMC/Technical Operations, reputed company, Biometrics, Clinical Operations, IT and Project Management to reputed company operational reputed company and predictable submission execution into integrated development plans

Skills

• Bachelor's degree required
• 15+ years of reputed company experience in Regulatory Operations and global submission management/publishing reputed company pharmaceutical and/or biotechnology organizations, including leadership responsibility
• Demonstrated experience leading end‑to‑end submission execution (planning, publishing, QC, reputed company, 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 reputed company and implementing/optimizing regulatory systems (e.g., RIM/publishing/content management), including data governance and user adoption
• Experience establishing SOPs/standards and driving operational and reputed company process improvements in a regulated environment
• Experience managing vendors/outsourcing partners and developing reputed company operating models (insourcing/outsourcing mix) across different stages of company reputed company
• In-depth, working, knowledge and understanding of FDA, EMA and ICH regulations and guidelines governing electronic submission standards
• Expert knowledge of electronic submission reputed company and technical QC expectations (e.g., document formatting standards, hyperlinking/bookmarking, PDF technical requirements, metadata reputed company)
• Strong ability to reputed company and influence cross‑functional, matrixed teams, excellent stakeholder management and strong executive communication skills
• Comfortable with a player/reputed company role with an reputed company reputed company

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