Teams at Secura Bio

Leads regulatory operations across a biotechnology development portfolio, including RIMS implementation and management, submission planning, eCTD publishing, document control, health authority correspondence, vendor oversight, and inspection readiness. Coordinates cross-functional regulatory deliverables, maintains submission records and trackers, establishes operational procedures, and supports the preparation and refinement of regulatory documents for global filings.

Manages end-to-end clinical supply planning and execution for global clinical development programs. Oversees forecasting, inventory, manufacturing, packaging, distribution, logistics, vendor relationships, quality activities, and risk mitigation. Coordinates Clinical Operations, Quality, Regulatory, Finance, contract manufacturers, depots, packaging vendors, and logistics providers to ensure uninterrupted product availability, regulatory compliance, and timely delivery. Supports budgeting, inspections, change controls, investigations, reporting, and continuous improvement.

Promote Copiktra to oncology providers within a Southeast territory, drive on‑label sales, develop territory business plans, present clinical data, engage cross‑functional partners, attend conferences, and ensure compliance with pharma regulations and company policies.