Job Description
Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. With guidance and supervision from supervisor and/or Senior Submission Manager, the Submission Manager is responsible for leading and coordinating the global compilation and worldwide submission of dossiers for new chemical and biological marketing authorization applications, complex life cycle dossiers and the related health authority responses based on regulatory strategies. This role will independently perform those activities for original INDs as well as perform select responsibilities of the US Regulatory Affairs (RA) Product Managers. Maintain associated U.S. RA data in RIM systems. With limited guidance, the Submission Manager will act as an expert in process development, e-Submission-specific requirements, and the development of regulatory strategies for unique situations. This role will lead and coordinate outsourced work packages performed by the external service provider. The incumbent will mentor and assist the Submission Management Specialist II with IND/NDA maintenance submissions as necessary. Responsibility for this role also includes governance for U.S., Regional and local OPUs in the Americas. When assigned, the Submission Manager will take a lead role in managing (multi-million dollar) user fee budget and payments. This role encompasses planning, tracking, and reporting as well as governance for assigned projects. Duties & Responsibilities Manages the planning, preparation and submission of original marketing authorization applications, complex lifecycle dossiers and related responses to health authorities in collaboration with RA sub team and contributing disciplines, with support and supervision from supervisor and/or Specialist IV Independently performs these activities for original INDs Maintains associated U.S. RA data in RIM systems Leads and coordinates work packages performed by external service providers and quality check information entered by providers in RIM systems Independently governs work packages outsourced to external service provider through continuous monitoring to ensure proper and consistent quality and compliance As necessary, acts as a facilitator between RA manager and service provider Ensures timelines are communicated and adhered to Checks the quality of the work according to internal guidelines and facilitate the resolution of any issues that may arise As requested, represents US Submission Management at meetings with the external service provider to share experiences and resolve issues Provides documentation (guides, checklists) and training for internal BI colleagues and external service provider as required For select submission types, assumes the responsibilities of the assigned RA product manager for content approval and release of a submission, including authoring RA documents and completing the submission content plan Develops and maintains advanced regulatory expertise for planning, compilation, delivery of electronic submissions, including BI global eSubmission standards, tools, and processes Acts as Subject Matter Expert for specific topics owned by this role and/or Key User for specific systems used by this role Develops and applies strategies for eCTD submissions and global rollout as needed Provides regulatory guidance on the interpretation and implementation of eSubmission-related regulatory requirements or comments/questions from Health Authorities Interfaces with regulatory authorities on submission-related topics as necessary to clarify requirements Participates in external industry/ regulators/ vendor groups (EFPIA, PhRMA, ICH) Develops and implements processes and standards across GRO and provide governance through continuous monitoring to ensure proper and consistent application Identifies potential new processes/standards or optimizations for existing processes/standards for submissions; participates in and where appropriate, lead efforts to develop and implement in collaboration with other applicable functions Prepares, updates, and reviews internal procedural documentation for processes and standards