enGene (NASDAQ: ENGN)is a late-stage biotechnology company focused on delivering genetic medicines to mucosal tissues and other organs. Our lead product candidate, detalimogene voraplasmid, is 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 cargo sizes, including DNA and various forms of RNA. For more information, visit enGene.com. RoleenGene 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.
Essential Duties And 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, and 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.
Skills:
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.
Required Experience And Qualifications:
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.
Location: USA Boston Massachusetts
Salary:
The salary range for this role is $145k-$185kThe base salary range provided represents a good faith estimate of the compensation for this position at the time of posting. Actual compensation will be determined based on a number of factors, including, but not limited to, relevant skills, experience and education.enGene USA Inc. is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
