Manager/Senior Manager, Regulatory Affairs Operations

enGene • Boston, MA

3d • $145 - $185 • Hybrid

About The Position

enGene (NASDAQ: ENGN) is a late-stage biotechnology company, mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead product candidate, detalimogene voraplasmid, is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive to BCG. Detalimogene voraplasmid was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com . Role enGene is seeking a highly motivated and detail-oriented Senior Manager, Regulatory Affairs Operations, to join our team. Reporting to the Director, Regulatory Affairs, this individual will be responsible for the execution of Regulatory Submissions operational activities in support of our program(s). In this role, you will be responsible for the execution of Regulatory Submissions operational activities in support of program(s). Primary responsibilities include the formatting and publishing of documents that support our program(s), oversight of our electronic submissions (eCTD) vendor, and management of Regulatory archives, submission templates, and Agency correspondence. Individuals may be fully remote or based in our Boston, MA headquarters. Our office-based employees are required to work in the office three (3) days a week – Tuesday, Wednesday, and Thursdays.

Requirements

• Comprehensive understanding of the pharmaceutical industry
• Deep knowledge of global regulatory submission types and requirements, including INDs, NDAs, BLAs, CTAs, MAAs, and related documentation.
• Expertise in submission publishing software and document formatting standards (e.g., eCTD).
• Strong experience with SharePoint.
• Solid understanding of ICH, FDA, EMA, and other regional submission guidelines.
• Meticulous attention to detail with strong organizational and quality assurance skills.
• Excellent verbal and written communication skills.
• Collaborative mindset with the ability to work effectively in cross-functional teams.
• Adaptable, solutions-oriented, and comfortable operating in an evolving regulatory landscape.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level