Senior Specialist

Description

• Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Collaborate with teams to execute the Global Submission Plan.
• Track and ensure timely progress of submission components to Health Authorities.
• Execute submission management and publishing activities in the eCTD publishing tool for efficient eCTD production and delivery through HA portals.
• Represent team in regulatory/submission meetings driving deliverable and publishing timelines.
• Participate in department initiatives within scope.
• 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.
• Continuous Improvement Initiatives
• Support initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.
• Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
• Ensure consistency of IND and marketing applications across projects, studies, and countries, aligning with regulatory standards and best practices.

Qualifications

• Required degrees, certifications, and/or licensure relevant to role. BA/BS degree, science / technology field preferred
• Minimum number of years of relevant experience expected. 3+ years relevant submissions experience
• Foundational knowledge of global regulatory practices, submission guidelines, and requirements
• Strong critical thinking and problem-solving skills; proposes alternative solutions for submission-related and project situations
• Effective stakeholder engagement and communication, including proficiency in English (written and oral) and ability to communicate with non-English speakers.
• Ability to execute and prioritize non-complex projects with attention to detail; communicates project status and updates to relevant stakeholders
• Demonstrates basic presentation skills and adapts content for diverse audiences
• Proficiency with desktop software and regulatory systems with the ability to instruct others; understand how non-regulatory systems interact with regulatory systems. Embrace the use of artificial intelligence and automation tools.