Associate Director, Regulatory Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the selection, implementation, validation, launch, and continuous management of the Regulatory Information Management System, encompassing system requirements, configuration, data migration, user testing, training, governance, and data quality.

• Create and uphold integrated plans, timelines, trackers, and dashboards for regulatory submissions and key portfolio deliverables.

• Direct the operational preparation, quality assurance, publishing, submission, tracking, and archiving of INDs, CTAs, amendments, annual reports, DSURs, briefing packages, health authority responses, and other regulatory filings.

• Organize document readiness, review cycles, approvals, version control, and transfer to publishing across Regulatory Affairs and cross-functional contributors.

• Ensure complete and precise regulatory records are maintained, including submissions, acknowledgments, health authority correspondence, commitments, approvals, and significant regulatory decisions.

• Develop and maintain regulatory operations procedures, templates, standards, naming conventions, and document-management practices that uphold data integrity and inspection readiness.

• Oversee regulatory operations vendors, publishing providers, system vendors, and consultants to guarantee delivery according to agreed timelines, quality standards, scopes, and budgets.

• Facilitate submission planning meetings and regulatory workstreams; monitor decisions, dependencies, risks, and action items until completion.

• Collaborate with Regulatory Affairs, Clinical, CMC, Nonclinical, Safety, Quality, Medical Writing, and Information Technology to support global regulatory deliverables.

• Keep abreast of changes in electronic submission requirements, eCTD standards, regulatory technology, and health authority expectations, updating processes as necessary.

• Assist in the preparation and refinement of regulatory documents, including formatting, document cleanup, content organization, and resolution of comments to ensure clear, consistent, submission-ready materials.

• Compose and edit routine regulatory content and coordinate cross-functional input while collaborating with Regulatory Affairs leadership and subject-matter experts on substantive scientific and strategic content.

⛳️ Requirements

• A bachelor's degree in life sciences, information management, business, or a related field; an advanced degree or relevant certification is preferred.

• A minimum of 8 years of experience in Regulatory Affairs or Regulatory Operations within the biotechnology or pharmaceutical sector.

• Proven experience in implementing or significantly expanding a RIMS, including requirements definition, configuration, data migration, testing, training, governance, and system administration.

• In-depth knowledge of IND lifecycle management, global regulatory submission processes, eCTD requirements, document management, and electronic publishing workflows.

• Experience in managing multiple concurrent submissions, intricate timelines, and cross-functional deliverables in a clinical-stage environment.

• Background in managing regulatory vendors, consultants, or external publishing providers.

• Exceptional project management, organization, communication, and problem-solving skills, with the ability to identify risks and escalate issues appropriately.

• Capability to work independently, establish practical processes, and manage competing priorities in a lean, fast-paced biotechnology company.

• Preferred: experience in supporting oncology, hematology, rare disease, or innovative clinical development programs.

• Preferred: experience with FDA, EMA, Health Canada, MHRA, or other global health authorities.

• Preferred: experience with Veeva Vault Regulatory or a similar RIMS and electronic document management platform.

• Preferred: experience in supporting health authority meetings, clinical trial applications, and inspection or audit readiness.

🏝️ Benefits

• Comprehensive health insurance plans.

• Generous paid time off and vacation policies.

• Opportunities for professional development and growth.

• Collaborative work environment with a focus on innovation.