Manager I, 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 JobsManager I, Submission ManagementBogotá - CO No longer accepting applications.Job IDR1603685Date 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 leyPosition Summary The Manager, Submission Management supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities and supporting continuous improvement initiatives.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 drive the execution of the Global Submission Plan.Track and ensure timely progress of eCTD 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 teamsContinuous Improvement InitiativesDrive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.Lead the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.Ensure cross functional alignment for IND and marketing applications across projects, studies, and countries, aligning with regulatory standards and best practices.Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement.Degree RequirementsBA/BS degree, science / technology field preferredExperience Requirements3+ years relevant submissions experienceKey Competency RequirementsProficient knowledge of global regulatory practices, eCTD submission guidelines as a MUST have, and requirements; able to identify and resolve issues with support from senior team membersStrong analytical and critical thinking skills for solution development, decision-making, and implementation; generates alternative solutions by weighing risks and dependenciesEffective communication skills in English (written and oral), including presenting complex information and collaborating with non-English speakersSolid project management abilities, defines objectives, sets...