Associate Director, Regulatory Operations

Secura Bio, Inc.

. 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.

Posted 9/25/2026full-timeRemote • United StatesSenior💰 $172,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Information Management Systems (RIMS) implementation, regulatory submission processes, and project management within the biotechnology or pharmaceutical industry. Proficient in managing regulatory operations, vendor relationships, and ensuring compliance with global health authority standards.

Highest-signal resume keywords

Regulatory Information Management System (RIMS) ImplementationIND Lifecycle ManagementGlobal Regulatory Submission ProcessesProject ManagementRegulatory Operations Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data MigrationUser TestingDocument ManagementElectronic Publishing WorkflowsRegulatory FilingsQuality ControlSubmission PlanningGovernanceDocument ReadinessVersion Control

Soft Skills

Excellent CommunicationProblem-SolvingOrganizationProject ManagementAbility to Work Independently

Tools & Technologies

Veeva Vault RegulatoryElectronic Document Management Platform

Certifications & Qualifications

Advanced Degree in Life SciencesRelevant Certification in Regulatory Affairs

Industry Keywords

BiotechnologyPharmaceuticalFDAEMAHealth CanadaMHRAOncologyHematologyRare DiseaseClinical Development

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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