Lead the implementation and ongoing management of the Regulatory Information Management System, and plan, coordinate, quality-check, publish, track, and archive regulatory submissions. Establish regulatory operations processes and records practices, manage vendors and cross-functional workstreams, and ensure submissions and documents meet applicable requirements and timelines.
About the Role
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.
Employment Type
Full-time
Reports To
Senior Director, Head of Regulatory Affairs
Key Responsibilities
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.
Required 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.
Preferred Qualifications
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.
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