Associate Director, Regulatory Operations

🕒 Setembro 25

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $172.000 - $210.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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Secura Bio, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2019

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 $90.000.000 Debt Financing - Secura Bio em 2019-03

Healthcare • Manufacturing • Biotechnology

Secura Bio, Inc. é uma empresa biofarmacêutica em fase comercial focada no desenvolvimento, comercialização e otimização de terapias oncológicas. A empresa enfatiza a estratégia comercial e o acesso ao mercado para medicamentos oncológicos, apoiada por capacidades de desenvolvimento clínico (ensaios clínicos, acesso expandido, estudos patrocinados por investigadores), educação médica e programas de apoio ao paciente. Sediada em Berkeley Heights, Nova Jersey, com um escritório em Dublin, Irlanda, a Secura Bio se posiciona para maximizar os resultados comerciais para tratamentos de câncer como duvelisib.

Descrição

• 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.

🎯 Requisitos

• 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.