Manager/Senior Manager, Regulatory Affairs Operations
enGene
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $145,000 - $185,000 per year
Job Level
About the role
- 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.
Requirements
- A bachelor’s degree or related experience is required.
- Minimum of 5 years in the pharmaceutical Regulatory Operations industry
- Experience managing, and publishing, eCTD submissions to health authorities with knowledge of US, EU, and Canada regional requirements.
- Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required.
- Extensive knowledge of global regulatory and compliance requirements.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
eCTD submissionsregulatory submissionsdocument formattinglifecycle managementcompliance processesregulatory operationssubmission quality assurancechecklists creationSOPs developmentuser guides creation
Soft skills
leadershipcollaborationcommunicationorganizational skillsattention to detailproblem-solvingtime managementsubject matter expertise