Manager/Senior Manager Regulatory Operations

Company: Beam Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

This role will be responsible for planning, scheduling and coordination of regulatory submissions (INDs, DMFs, CTAs, etc.) in collaboration with internal program teams and external publishing partners. This individual will also serve as the administrator for Beam---s regulatory information management system. This position is a key contributor to enable high-quality and timely regulatory submissions.Responsibilities:Provides direct support to program teams and functional disciplines responsible for developing and delivering components for regulatory submissions.Manages all aspects of document workflows associated with submission authoring, review, compilation and publishing for various dossier typesDevelops and manages day-to-day submission plans in accordance with program timelines in collaboration with CRO publishing partners.Works with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templatesServes as the administrator for Beam---s regulatory information management system and provide Subject Matter Expertise to support project teams in the development of components for various regulatory submissions.Develops and maintains efficient tracking mechanisms for all global regulatory information including the archiving and storage of both electronic and hard copy records (if applicable).Monitors evolving global regulatory guidance/regulations and ensures Beam---s regulatory submissions comply with all document/file formats and structuresAuthors and/or collaborates on standard operating procedures for the regulatory operations function.Perform other related duties as assigned.Qualifications:BS in a scientific discipline or systems technology or equivalent5-7 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)Strong expertise and working knowledge of eCTD publishing systems, EDMS technology, and related publishing toolsAdvanced knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)Computer proficiency in Microsoft Office including Word, Excel, PowerPoint, and Project.Preferred8-10 years of pharmaceutical experience in an R&D environmentExperience in the preparation and submission of documents using regulatory/document management systems5 years of technical support and Information Management experiences from User support and strategic level, preferably within a corporate environment supporting multi-user systems.

Keywords: Beam Therapeutics, Somerville , Manager/Senior Manager Regulatory Operations, Executive , Somerville, Massachusetts