Senior Director, Head of Regulatory Operations & Compliance

Submission Management:

• Set submission strategy and operational timelines in partnership with Regulatory Strategy and the cross‑functional teams.
• Oversee submission formatting, publishing, QC and archival in accordance with global standards.
• Lead the operational planning and execution of global regulatory submissions.

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.

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.
• Support inspections/audits, and partner with QA to address inspection findings, ensuring continuous improvement in alignment with quality system principles.