Company Overview

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The Sr. Associate, Regulatory Information Systems will be responsible for supporting the planning, scheduling and coordination of regulatory submissions (INDs, DMFs, CTAs, etc.) in collaboration with internal program teams and external publishing partners. This position is a key contributor to enable high-quality and timely regulatory submissions.

Responsibilities:

• Provides direct support to the Sr. Manager, Regulatory Operations for all aspects of the regulatory submission process
• Processes health authority submissions in partnership with regulatory leads and under the guidance and with the support of the Sr. Manager, Regulatory Information Systems
• Manage ex-US submission portals (e.g. CTIS, IRAS) and process submissions through these portals
• Will serve as a key resource for program teams and functional disciplines responsible for developing and delivering components for regulatory submissions
• Ensures document creation workflow process is properly completed.
• Assists with the development and management of the day-to-day submission plans in accordance with program timelines in collaboration with CRO publishing partners
• Maintains all global regulatory information including the archiving and storage of both electronic and hard copy records (if applicable) efficiently
• Where applicable, monitors evolving global regulatory guidance/regulations and ensures Beam’s regulatory submissions comply with all document/file formats and structures
• Reviews and provides feedback of authored standard operating procedures and/or collaborates on for the regulatory operations function
• Suggests process improvements and when appropriate works to implement suggested improvements
• Perform other related duties as assigned

Qualifications:

• Bachelor’s degree in a scientific discipline or systems technology or equivalent experience with 6+ years experience; 3-5 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
• 2+ of technical support and Information Management experiences from User support and strategic level, preferably within a corporate environment supporting multi-user systems
• Experience in the preparation and submission of documents using regulatory/document management systems (Veeva RIM and StartingPoint experience are a must)
• Familiarity 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.