enGene

Director/Senior Director, Regulatory Affairs Operations

enGene

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Senior

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.).
  • 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).
  • Manage the preparation, publishing, and archiving of submissions to global health authorities; guide internal teams on technical and regional requirements.
  • Play a key strategic role in supporting the Global RA 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.
  • Report directly to the Chief Regulatory Officer and lead best practices across regulatory systems and processes.

Requirements

  • 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.
  • 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 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.