Apply on Employer Site

enGene · 1 day ago

Manager/Senior Manager, Regulatory Affairs Operations

Boston, MA

Full-time

Hybrid

Mid, Senior Level

5+ years exp

enGene is a late-stage biotechnology company focused on delivering genetic medicines. They are seeking a highly motivated Senior Manager of Regulatory Affairs Operations to lead regulatory submissions and ensure compliance with global regulatory agencies.

BiotechnologyDiabetesGeneticsHealth Care

Responsibilities

Lead the day-to-day regulatory operations activities across assigned programs, ensuring timely, high-quality submissions to global regulatory agencies (FDA, EMA, etc.). Responsibilities include providing advice on content and structure of submissions, attending meetings, providing templates, and formatting and publishing documents

Oversight of enGene’s eCTD vendor. Responsibilities include ensuring formatting, publishing, and submission of document quality for INDs, NDAs, BLAs, CTAs, MAAs, adherence to Agency regulations/guidance

Create Regulatory Operations process Checklists, User Guides, SOPs and Work Instructions

Schedule, monitor, and track Regulatory submissions to ensure corporate and health authority deadlines are met

Management of submissions archives and correspondence

Serve as subject matter expert on regional and technical submission requirements and regulatory document formatting

Collaborate cross-functionally with Regulatory Affairs, Clinical, Quality, and CMC to ensure submission readiness and compliance

Qualification

Regulatory submissions expertiseECTD publishing softwareGlobal regulatory knowledgePharmaceutical industry understandingSharePoint experienceAttention to detailOrganizational skillsCommunication skillsCollaborative mindsetAdaptability