[Hiring] Associate Director, Regulatory Operations @Secura Bio, Inc.

Role Description

The Associate Director, Regulatory Operations, will lead regulatory operations across Secura Bio's development portfolio. This individual will build and manage the Regulatory Information Management System, lead submission planning and execution, and establish efficient processes for regulatory records, document management, publishing, and health authority correspondence. The role will work closely with Regulatory Affairs leadership, cross-functional teams, consultants, and vendors to ensure timely, high-quality regulatory submissions.

Qualifications

• Bachelor's degree in life sciences, information management, business, or a related field; advanced degree or relevant certification is preferred.
• At least 8 years of experience in Regulatory Affairs or Regulatory Operations within the biotechnology or pharmaceutical industry.
• Demonstrated experience implementing or significantly expanding a RIMS, including requirements definition, configuration, data migration, testing, training, governance, and system administration.
• Strong knowledge of IND lifecycle management, global regulatory submission processes, eCTD requirements, document management, and electronic publishing workflows.
• Experience managing multiple concurrent submissions, complex timelines, and cross-functional deliverables in a clinical-stage environment.
• Experience managing regulatory vendors, consultants, or external publishing providers.
• Excellent project management, organization, communication, and problem-solving skills, with the ability to identify risks and escalate issues appropriately.
• Ability to work independently, establish practical processes, and manage competing priorities in a lean, fast-paced biotechnology company.

Requirements

• Experience supporting oncology, hematology, rare disease, or novel clinical development programs.
• Experience with FDA, EMA, Health Canada, MHRA, or other global health authorities.
• Experience with Veeva Vault Regulatory or a comparable RIMS and electronic document management platform.
• Experience supporting health authority meetings, clinical trial applications, and inspection or audit readiness.

Salary

$172,000 - $210,000