Manager I

Description

• Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Collaborate with teams to drive the execution of the Global Submission Plan.
• Track and ensure timely progress of submission components to Health Authorities. Apply risk and critical path management practices.
• Execute submission management and publishing activities in the eCTD publishing system for efficient eCTD production and delivery to HA portals.
• Lead/represent team in regulatory/submission meetings driving deliverable and publishing timelines.
• Lead/participate in department initiatives within scope. Develop/update procedural documentation as needed.
• Execute required activities in RIM systems (Veeva RIM) and use available tools to generate reports and track submission content.
• Coordinate non-eCTD submissions with international teams.
• Partner with Regulatory CMC, Manufacturing, Quality, Analytical Development, and Technical Operations teams to plan, coordinate, and track CMC documentation required for global regulatory submissions and health authority interactions.
• Manage the submission readiness of CMC content for INDs, IMPDs, BLAs, NDAs, MAAs, lifecycle management submissions, variations, supplements, and responses to health authority questions.
• Ensure CMC submission components are complete, compliant, and aligned with current global regulatory requirements and company standards.
• Support regulatory assessment of manufacturing changes, process improvements, site transfers, specification updates, and other post-approval CMC changes impacting global submissions.
• Coordinate CMC contribution to health authority requests, deficiency responses, inspections, and agency meeting packages.

Qualifications

Highest qualification: University

• BA/BS degree, science/technology field preferred.
• 5+ years relevant submissions experience.
• Proficient knowledge of global regulatory practices, submission guidelines, and requirements; able to identify and resolve issues with support from senior team members.
• Strong analytical and critical thinking skills for solution development, decision-making, and implementation; generates alternative solutions by weighing risks and dependencies.
• Effective communication skills in English (written and oral), including presenting complex information and collaborating with non-English speakers.
• Solid project management abilities: defines objectives, sets priorities, tracks progress, manages resources, and communicates status and risks within project teams.
• Builds collaborative relationships by understanding stakeholder needs, priorities, and processes; drives team communication for successful project delivery.
• Advanced proficiency with desktop software and regulatory systems with the ability to instruct others; understands how non-regulatory systems interact with regulatory systems. Embrace the use of artificial intelligence and automation tools.
• Experience supporting Regulatory CMC activities and managing CMC submission components for development and/or commercial products.
• Understanding of pharmaceutical and/or biologics manufacturing processes, quality systems, lifecycle management, and global CMC regulatory requirements.
• Experience with Module 3 content, CMC document management, and lifecycle submissions in major markets (FDA, EMA, PMDA, Health Canada, and other global health authorities) is preferred.
• Knowledge of manufacturing change management and regulatory impact assessments is highly desirable.