Senior Specialist, Submission Management

Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsSenior Specialist, Submission ManagementBogotá - CO No longer accepting applications.Job IDR1603686Date posted06/17/2026DepartmentNot ApplicableBristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.The Senior Specialist Submission Management supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities.Position ResponsibilitiesRegulatory (IND and Marketing) Submission ManagementCollaborate 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 availabile tools to generate reports and track submission content.Coordinate non-eCTD submissions with international teams.Continuous Improvement InitiativesSupport initiatives that promote innovation and simplify processes to enhance efficienices 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.Degree Requirements BA/BS degree, science / technology field preferredExperience Requirements 1-2+ years relevant submissions experienceFoundational knowledge of global regulatory practices, submission guidelines, and requirementsStrong critical thinking and problem-solving skills; proposes alternative solutions for submission-related and project situationsEffective stakeholder engagement and communication, including proficiency in English (written and oral) and ability to communicate with non-English speakersAbility to execute and prioritize non-complex projects with attention to detail; communicates project status and updates to relevant stakeholdersDemonstrates basic presentation skills and adapts content for diverse audiencesProficiency 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 inteligence and automation tools.#LI-HybridThe Senior Specialist Submission Management...