Reporting directly to the Regulatory Operations Manager, the Regulatory Operations Associate is responsible for aspects of production, compilation, and submission of regulatory documents required for filing INDs, including original submissions, subsequent amendments and periodic reports to regulatory authorities. In addition, the position would entail regulatory document management responsibilities using Regenxbio’ s Veeva electronic document management system to manage and provide internal access to electronic copies of submissions and/or other regulatory communications.
Assist in the review, authoring, and compilation of tabulated and written summaries needed for preparation of required components for IND submissions.
Maintain regulatory timelines and eCTD tracking information coordinating completion of required components of IND by other contributing team members. Collaborate with contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions
Work with outside regulatory information management companies to ensure a quality final submission and meet internal deadlines
Act as Lead Publisher, for assign projects to publish and validates large and complex submissions to health authorities.
Utilizes expertise to function as a trainer or subject matter expert for an area of eCTD and electronic publishing.
Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs.
Assists with archiving of documents within the Veeva document management system
Provides additional support as needed for team communications on planning and logistics for health authority meetings and preparation of minutes
Bachelor’s degree in a relevant scientific discipline and 5 years pharmaceutical experience and minimum of or 2 years eCTD regulatory operations experience
IT capability and competence with identified systems and databases (Microsoft Office, document management and eCTD publishing systems, archiving software)
RAPS certificate and experience with ISI ToolBox, Starting Point templates, and Veeva Vault a plus.
Ability to work independently with minimal supervision on multiple projects simultaneously.
Understanding of drug development and regulatory requirements (standards, quality, timeliness)
Organizational and planning ability
Strong attention to detail and quality
Good interpersonal and communication skills
Ability to manage and prioritize a variety of project tasks
Experience working with interdepartmental project teams
Internal Number: REG01
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.
Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. We are currently developing gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases. Our product candidates all utilize AAV viral vectors from our proprietary gene delivery platform, which we call our ...NAV Technology Platform. In addition to our internal product candidate programs, we also selectively license our NAV Vectors to other leading biotechnology companies.