Precision BioSciences, Inc.

Compliance

• Drives timely submission and approval of routine and substantive regulatory submissions including initial trial applications (e.g. IND, CTA) and marketing applications, with support and guidance from senior regulatory management as needed
• Coordinates and prepares document packages for regulatory submissions to ensure alignment and compliance with applicable regulations and guidelines
• Leads and guides content generation, with input from other functions and external vendors, to ensure timely and successful compilation of complex multidisciplinary content for regulatory submissions
• Manages relationships cross functionally with internal teams, including program teams, CMC, Clinical, Translational, Quality and external partners to execute routine regulatory activities
• Ensures submissions are compliant with local and regional registration requirements as well as with company policies
• Performs regulatory research to keep abreast of regulatory procedures, FDA/EMA/ICH guidance and policy trends and provides guidance to internal teams to ensure compliance
• Supports Senior Director, Regulatory Affairs with FDA (or other health authority) meeting strategy and execution, briefing package and questions development, agency correspondence and alignment on regulatory expectations
• Partners closely with Senior Director, Regulatory Affairs to support regulatory strategy, long-range regulatory planning, and other regulatory duties, as assigned
• Maintains and improves tracking and archival systems to ensure efficient and compliant operations for regulatory submission preparation and archival
• Develops new regulatory operations procedures and best practices
• Coordinates external regulatory operations activities with outside partners (i.e. publisher, external consultants)
• Supports the preparation for regulatory authority interactions, meetings and inspections

Manager, Regulatory Affairs

Program Manager

• Design and implement translational strategies for the efficient advancement of clinical programs from phase 1 through pivotal clinical trials.
• Collaborate with Development Program Leaders to integrate, document, and communicate Translational plans, track progress, and re-forecast as necessary in conjunction with the team.
• Maintain close working relationships with translational team members and functional departments (e.g., Research, Nonclinical, CMC, Clinical, Regulatory, Quality, Program Management) to ensure that all critical parties are aware of translational activity, issues, and contingencies.
• Demonstrate a strong appreciation for research with a focus on translational science and product development.
• Track key milestones, deliverables, risks and dependencies, flag potential delays, and drive mitigation plans.
• Organize team meetings including agendas, pre-work, minutes, action items and overall translational team correspondence including management of timelines, deliverables, metrics, and budget.
• Develop and implement communication tools that enhance information exchange and stimulate creative project interactions.
• Work in concert with Program Leaders in preparing slide decks and information for ongoing project team meetings, reviews, board meetings, scientific presentations, and other appropriate meetings that involve progression through the key decision points of a program.
• Be a champion of change, propose solutions to problems, support company decisions, and help teams to understand factors and priorities leading to decisions.

Manager, Regulatory Affairs

Senior Program Manager, Translational Science