Associate Director, Regulatory Operations

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $172.000 - $210.000 / Jahr

⏰ Vollzeit

🟠 Senior

🚔 Compliance

👻 Geisterscore 0%

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• Seit 51 Tagen offen.
• Stellen bei diesem Unternehmen werden meist in 61 Tagen besetzt.

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Secura Bio, Inc.

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2019

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

💰 €90.000.000 Debt Financing - Secura Bio im 2019-03

Healthcare • Manufacturing • Biotechnology

Secura Bio, Inc. ist ein biopharmazeutisches Unternehmen im kommerziellen Stadium, das sich auf die Entwicklung, Vermarktung und Optimierung von Krebstherapien konzentriert. Das Unternehmen legt Wert auf kommerzielle Strategien und Marktzugang für Krebsmedikamente, unterstützt durch Fähigkeiten in der klinischen Entwicklung (klinische Studien, erweiterter Zugang, von Forschern gesponserte Studien), medizinische Bildung und Patientenunterstützungsprogramme. Mit Hauptsitz in Berkeley Heights, New Jersey, und einem Büro in Dublin, Irland, positioniert sich Secura Bio, um die kommerziellen Ergebnisse für Krebstherapien wie Duvelisib zu maximieren.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

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