Secura Bio, Inc.

Account Manager

• Promote Copiktra and other approved drugs fairly and consistently with approved indications
• Educate health care providers on the on-label use of Copiktra using approved promotional materials
• Develop and execute territory business plans aligned with corporate strategic objectives
• Conduct monthly business reviews, analyze progress, identify opportunities and risks, and implement data-driven adjustments
• Achieve on-label sales growth and meet sales targets and performance metrics
• Monitor operating costs and manage the territory budget
• Identify key practice decision-makers
• Conduct promotional presentations, informational in-services, and educational programs
• Support commercial presence at appropriate medical congresses in the territory
• Engage Medical Science Liaisons and Medical Affairs contacts to address customer questions
• Collaborate with Market Development, Market Access, Medical Affairs, and Marketing teams
• Comply with Secura Bio policies and applicable laws
• Report to the VP, US Sales, Market Access and Operations

Key Account Manager

Compliance

• Lead the selection, implementation, validation, launch, and ongoing management of the Regulatory Information Management System, including system requirements, configuration, data migration, user testing, training, governance, and data quality.
• Develop and maintain integrated plans, timelines, trackers, and dashboards for regulatory submissions and key portfolio deliverables.
• Lead the operational preparation, quality control, publishing, submission, tracking, and archival of INDs, CTAs, amendments, annual reports, DSURs, briefing packages, health authority responses, and other regulatory filings.
• Coordinate document readiness, review cycles, approvals, version control, and transfer to publishing across Regulatory Affairs and cross-functional contributors.
• Maintain complete and accurate regulatory records, including submissions, acknowledgments, health authority correspondence, commitments, approvals, and key regulatory decisions.
• Establish and maintain regulatory operations procedures, templates, standards, naming conventions, and document-management practices that support data integrity and inspection readiness.
• Manage regulatory operations vendors, publishing providers, system vendors, and consultants to ensure delivery against agreed timelines, quality standards, scopes, and budgets.
• Facilitate submission planning meetings and regulatory workstreams; track decisions, dependencies, risks, and action items through completion.
• Partner with Regulatory Affairs, Clinical, CMC, Nonclinical, Safety, Quality, Medical Writing, and Information Technology to support global regulatory deliverables.
• Monitor changes in electronic submission requirements, eCTD standards, regulatory technology, and health authority expectations and update processes as needed.
• Support the preparation and refinement of regulatory documents, including formatting, document cleanup, content organization, and resolution of comments to ensure clear, consistent, submission-ready materials.
• Draft and edit routine regulatory content and coordinate cross-functional input, while partnering with Regulatory Affairs leadership and subject-matter experts on substantive scientific and strategic content.

Key Account Manager

Associate Director, Regulatory Operations