enGene
Director/ Senior Director, Regulatory Affairs Operations
enGene, Boston, Massachusetts, us, 02298
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 Head of Regulatory Affairs Operations to join our team. This key leadership role is ideal for a seasoned Regulatory Operations leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company. In this role you will support global regulatory submissions, document management, and cross-functional collaboration to help deliver life-changing medicines to patients. In this pivotal role, you will oversee regulatory operations activities across development programs, ensuring compliant, efficient, and timely regulatory submissions. Reporting directly to the Chief Regulatory Officer, you will manage the preparation, publishing, and archiving of submissions to global health authorities, guide internal teams on technical and regional requirements, and lead best practices across regulatory systems and processes. This position is ideal for a seasoned Regulatory Operations leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company. 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.). Oversee preparation, formatting, publishing, and submission of documents for INDs, NDAs, BLAs, CTAs, MAAs, supplements, briefing documents, and more. Oversee the implementation of an Electronic Document Management System (EDMS). Play a key strategic role in supporting the Global Regulatory Affairs business by overseeing all regulatory submissions globally to ensure proper resourcing, planning and on-time execution from a project management and submission support perspective. 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 (eCTD). Strong experience with Electronic Document Management Systems (EDMS) and 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
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology, or related field) required; advanced degree preferred. Minimum 8 years in the pharmaceutical/biotech industry, including 7+ years of direct Regulatory Operations experience. Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required. Demonstrated leadership skills and the ability to work collaboratively. Extensive knowledge of global regulatory and compliance requirements. Ability to use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance. 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 endeavour to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.
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enGene is seeking a highly motivated and detail-oriented Head of Regulatory Affairs Operations to join our team. This key leadership role is ideal for a seasoned Regulatory Operations leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company. In this role you will support global regulatory submissions, document management, and cross-functional collaboration to help deliver life-changing medicines to patients. In this pivotal role, you will oversee regulatory operations activities across development programs, ensuring compliant, efficient, and timely regulatory submissions. Reporting directly to the Chief Regulatory Officer, you will manage the preparation, publishing, and archiving of submissions to global health authorities, guide internal teams on technical and regional requirements, and lead best practices across regulatory systems and processes. This position is ideal for a seasoned Regulatory Operations leader who thrives in a nimble, hands-on environment and is excited by the opportunity to build and enhance operational infrastructure within a small but rapidly evolving biotech company. 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.). Oversee preparation, formatting, publishing, and submission of documents for INDs, NDAs, BLAs, CTAs, MAAs, supplements, briefing documents, and more. Oversee the implementation of an Electronic Document Management System (EDMS). Play a key strategic role in supporting the Global Regulatory Affairs business by overseeing all regulatory submissions globally to ensure proper resourcing, planning and on-time execution from a project management and submission support perspective. 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 (eCTD). Strong experience with Electronic Document Management Systems (EDMS) and 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
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology, or related field) required; advanced degree preferred. Minimum 8 years in the pharmaceutical/biotech industry, including 7+ years of direct Regulatory Operations experience. Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance and process are required. Demonstrated leadership skills and the ability to work collaboratively. Extensive knowledge of global regulatory and compliance requirements. Ability to use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance. 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 endeavour to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.
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