The Senior Director, Head of Regulatory Operations & Compliance, is a key leadership role within Regulatory Affairs, accountable for the regulatory submission excellence and compliance framework across the product lifecycle. Owns global submission execution, regulatory systems governance (RIM/publishing), and the RA compliance program and inspection readiness. Partners closely with Regulatory Strategy, QA, Clinical, CMC, and Medical Writing to deliver high-quality submissions and to maintain compliant, controlled processes and systems. Key Responsibilities Submission Management: Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams. Lead the operational planning and execution of global regulatory submissions (INDs/CTAs, NDAs/MAAs, post‑approval lifecycle submissions, HA interactions). Oversee submission formatting, publishing, QC and archival in accordance with global standards. Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams. Lead the operational planning and execution of global regulatory submissions (INDs/CTAs, NDAs/MAAs, post‑approval lifecycle submissions, HA interactions). Oversee submission formatting, publishing, QC and archival in accordance with global standards. Process & Systems: Build, evolve, and manage the Regulatory Operations infrastructure, including processes, standards, templates, and best practices. Own and optimize regulatory systems (RIM, publishing tools, controlled document systems), driving automation and efficiency. Partner with IT, QA, and system vendors to ensure appropriate lifecycle control for regulated systems. Build, evolve, and manage the Regulatory Operations infrastructure, including processes, standards, templates, and best practices. Own and optimize regulatory systems (RIM, publishing tools, controlled document systems), driving automation and efficiency. Partner with IT, QA, and system vendors to ensure appropriate lifecycle control for regulated systems. Compliance & Inspection Readiness: Maintain submission metrics and compliance tracking, including periodic reviews of archives, submission history, and audit trails. Lead the creation, implementation, and maintenance of RA SOPs, Work Instructions, and templates to ensure standardization and inspection readiness. Establish and oversee training on RA procedures and submission standards. Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles. Maintain submission metrics and compliance tracking, including periodic reviews of archives, submission history, and audit trails. Lead the creation, implementation, and maintenance of RA SOPs, Work Instructions, and templates to ensure standardization and inspection readiness. Establish and oversee training on RA procedures and submission standards. Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles. Team & Vendor Management: Build and lead a high‑performing regulatory operations team, oversee submission operating model and resource planning. Manage external vendors (publishing partners, systems providers, CROs) to ensure quality and performance aligned with company expectations. Build and lead a high‑performing regulatory operations team, oversee submission operating model and resource planning. Manage external vendors (publishing partners, systems providers, CROs) to ensure quality and performance aligned with company expectations. Cross-Functional Partnership: Partner with Regulatory Strategy to ensure alignment of operational plans. Serve as a key liaison with CMC, Clinical, PV, and Medical Writing to ensure efficient preparation of submission‑ready content. Collaborate closely with QA on procedural governance and RA‑related training. Partner with Regulatory Strategy to ensure alignment of operational plans. Serve as a key liaison with CMC, Clinical, PV, and Medical Writing to ensure efficient preparation of submission‑ready content. Collaborate closely with QA on procedural governance and RA‑related training.