Responsible for the management of the day-to-day Regulatory Operations functions and all submissions to Global Regulatory Authorities (i.e., FDA, EMA, etc.). This includes the development and implementation of Regulatory Operations infrastructure to support both electronic and paper submission filings, as required by Regulatory agencies. Creates processes and standard requirements to support all submission related activity. Works closely with Project/Program Teams to ensure that the company meets all key submission milestones. Provides leadership for the Regulatory Operations Team and guidance to other departments for full implementation of the Common Technical Document (CTD) and e-submission filings. Responsible for administration of Regulatory systems/databases and for implementing the use of authoring software/tools by contributors that are compatible with the Regulatory submission publishing system. Keeps current of regulatory submission publishing standards to ensure compliance with Regulatory Agency’s requirements. Selects and maintains effective relationships with external publishing vendors/contractors to help manage the Regulatory submission workload. Assists with operational training, procedures, and budgeting. Helps select, develop, and evaluate personnel to ensure the efficient operation of the Regulatory Operations function. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. Manages the Regulatory Operations function, and oversees and participates in the day-to-day submission activity. Makes final decisions on administrative or operational matters and ensures the Regulatory Operations' effective achievement of objectives. Helps recruit, and is responsible for the coaching/mentoring, development and performance reviews and feedback to direct reports. Drives the submission process; creates and supports the electronic management of regulatory submissions from clinical trial application (IND, CTA) to marketing approval (NDA, MAA). Responsible for managing the logistics, preparation, quality assurance, and delivery of regulatory submissions in accordance with Regulatory agency requirements, company standards, and timelines. Responsible for maintaining and strategies for improving Regulatory Affairs systems/processes for the efficient publishing and archiving of regulatory submissions. Contributes to the development and deployment of strategic solutions for the optimal capture, storage and workflow of all regulatory documents, contributing components and processes to ensure dossier delivery, submission publication, and regulatory submission filings. Collaborates with Regulatory Affairs and contributing functional areas to create submission project plans as well as identify and allocate internal and external resources (including vendors/CROs). Selects and works closely with regulatory submission vendors/contractors to efficiently manage regulatory submission workload. Responsible for ensuring Regulatory Affairs has resources (staffing and facilities) to maintain documentation. Interacts with internal and external executive management requiring skillful negotiations of complex matters to influence policy making bodies. Resolves significant conflicts and disputes within and/or across departments. Negotiates win/win scenarios for organizational productivity and efficiency. Reviews and manages regulatory departmental activities, ensuring alignment with company project timelines. Analyzes trends and evaluates the impact of changes in Regulatory Agency requirements for e-submissions; communicates changes to appropriate areas and implements required changes to submission filings to ensure compliance with required standards. Develops and provides in-house training, according to Regulatory and submission project team needs; this includes authoring templates, style guide formatting requirements, processes and tools critical to compiling all submission types. Participates in the writing and reviewing of Regulatory processes (SOPs, Work Instructions and internal guidelines). Provides Regulatory Operations guidance and information to Regulatory Affairs department and submission project teams Provides input to R&D department activities, including but not limited to; Regulatory Affairs staffing requirements, budget proposal and tracking, SOPs, training requirements, documentation retention policy and implementation, etc. Other duties as required.
A minimum of a Bachelors degree in a scientific discipline is required; equivalent experience may be accepted. A minimum of 10 years pharmaceutical or other related industry experience is required. A minimum of 8 years hands-on Regulatory Affairs/Operations experience and knowledge of pharmaceutical regulatory submission requirements for global filings (FDA and/or EMA, etc.) is required. A minimum of 10 years leadership/management experience may be required. Knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for US submission types (e.g. IND, DMF, NDA, PSUR etc.). Experience in publishing and compilation of eCTD submissions for US filings is required and experience publishing ex-US electronic submissions is desirable. Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools. Demonstrated leadership, organizational and planning skills. Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines. Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities. Excellent written and verbal interpersonal skills are required; these must be effectively used to influence many diverse internal and external customer groups. Must be experienced in staff and organizational development and problem solving, career and development planning, identifying training needs, and proactive resolution planning. Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project time-lines. Ability to manage changing departmental priorities, evaluate and assign resources, and communicate timeline and resource impacts to project teams and management is required.