Senior Specialist, CMC Submission Management

As a Regulatory Submissions Specialist at Bristol Myers Squibb, you will be responsible for ensuring the timely and accurate submission of documents to Health Authorities. Your role will involve interacting with various stakeholders to gather all necessary components for submissions and conducting submission publishing activities. Additionally, you will participate in focused projects within your scope of work and prepare submission documents for Investigational and Marketed Applications. Key Responsibilities: - Track, collect, and review all components for submission to Health Authorities - Perform submission publishing activities - Interact with responsible parties to ensure quality submission documents - Facilitate submission team meetings with support - Prepare Cover Letter, FDA Forms, and submission content plan for various submissions - Coordinate submission team meetings and drive submission publishing timelines - Develop and update job aid documents for departmental processes - Coordinate non-eCTD submissions with International Regulatory Team lead Qualifications Required: - Minimum of 5 years of relevant submissions experience - Foundational knowledge of global regulatory practices and submission guidelines - Proficiency in English language, both written and oral - Ability to prioritize tasks with strong attention to detail - Basic presentation skills to deliver content to various audiences - Intermediate-level working knowledge of common desktop software Educational Qualifications: - BA/BS degree in a science or technology field preferred If you are excited about a role that may not perfectly align with your current resume, Bristol Myers Squibb encourages you to apply anyway. Join a supportive culture that values individual talents and unique perspectives to make a difference in transforming patients" lives through science. Please note that the occupancy structure at BMS determines where you will be required to work based on the nature and responsibilities of your role. The company is committed to supporting individuals with disabilities through workplace accommodations and adjustments. Bristol Myers Squibb prioritizes the well-being of employees, customers, patients, and communities by strongly recommending full vaccination for Covid-19 and staying up to date with boosters. The company will consider applicants with arrest and conviction records in accordance with applicable laws. For applicants requiring accommodations during the recruitment process, please direct inquiries to adastaffingsupport@bms.com. More information on Equal Employment Opportunity and accessibility can be found at careers.bms.com/eeo-accessibility.,