Submission Manager

BoehringerPRD•Brampton, ON

5d•$90,000 - $147,000

About The Position

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.

Requirements

Master’s degree in scientific/technical discipline with three-plus (3+) years of related industry experience.
OR Bachelor’s degree in scientific/technical discipline with six-plus (6+) years related industry experience.
OR Minimum five to ten (5-10) years pharmaceutical industry experience.
Demonstrated leadership.
Strong communication and interpersonal skills are required.
Must be detail-oriented, well organized with excellent planning, project management and decision-making skills.
Ability to handle multiple priorities and act independently.
Demonstrated ability to develop collaborative partnerships with individuals they do not supervise.
Excellent verbal and written communication skills.
Demonstrated ability to manage conflicts and negotiate difficult situations.
Demonstrated flexibility and adaptability.
Ability to quickly adapt to and accept a changing environment and be willing to take on any task required to provide support to the Global Regulatory Operations organization.
Demonstrated learning agility.
Ability to learn and use new systems/tools, methodologies, and processes, while not jeopardizing quality.
Must take responsibility and ownership for timely decisions, actions/non-action, and results.
Must support execution of quality management principles and requirements.
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

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.
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.
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.
Provides or oversees training to applicable functions and vendors.
Represents GRO in strategic projects about global processes.
Presents status updates on progress to applicable functional areas inside and outside RA; reports critical issues or support needed to management.
When assigned, maintains detailed forecast of all user fees for upcoming submissions to FDA.
Leads the communications with Finance and RA leadership on user fee budget and ensures on time payments to FDA.
Takes the lead to perform impact-analysis as user fee schedules and requirements change and leads change implementation steps, including cross-functional collaboration as necessary.
Maintains awareness of product developments that necessitate new or changed user fees.
Clarifies requirements with FDA as needed.