OBJECTIVES

Provide project management capabilities and leadership to the Global Regulatory Department to ensure the successful delivery of Regulatory projects and milestones for drug development or marketed programs of appropriate complexity.Work closely with the Global Regulatory Lead (GRL), as well as members of other Regulatory sub-groups, to direct the team through the process of developing regulatory strategy, and translates the strategy into an executable plan.Utilize project management methodologies and tools to guide Regulatory teams in achieving operational excellence; driving teams to achieve clarity on issues, interfacing with management and supporting decision-making, while monitoring timelines. Act as an expert in regulatory project management within the Takeda organization.

ACCOUNTABILITIES

Manages the project planning efforts of the GRT in the definition and implementation of the Global Regulatory Strategy Plan (GRSP) as well as the operational plan and execution strategies with the team; obtains buy-in of all team members and is responsible for maintaining the GRSP document.Partner with Global Project Management (GPM) to ensure a seamless interface between Regulatory and the Global Project Team (GPT/EPT); and consolidate and maintain Global Regulatory project management information needed at the GPT/EPT.Maintain an integrated GRT deliverable projection for functional planning, in alignment with the GRSP and escalate timeline concerns or obstacles to the GRT, including risks and issues that may impact the project and engages appropriate representatives to manage outcomes. Follows issues through to resolution, ensuring that all GRT issues arrive at a conclusion or recommendation.Lead and manage GRTs in partnership with the GRL and drive project risk management processes and generate cross-Regulatory risk register for assigned projects. Identify project challenges, keeping leadership informed of critical considerations (e.g. resources, team health etc.)Consolidate and maintain Global Regulatory project management information needed at the Global Program Team (GPT); manages project status reporting to Senior Management and GPTs.Support Global Regulatory strategic initiatives and Regulatory involvement in related external projects; act as the project lead where required (e.g. Product divestments and in-licensing, large-scale manufacturing site changes, process engineering, interface with GPM Project Management Office, etc.)Consider opportunities for continuous Regulatory process improvement across therapeutic areas and marketed products; ensure cross-Regulatory alignment on related issues.Develop, communicate, and build consensus around team goals.Support the Global Regulatory Lead (GRL) in presenting strategies to key stakeholders and decision makers, such as Global Program Team (GPT) members and Regulatory leadership at Project Review Meetings and plan, manage preparation for, and attend Regulatory Health Authority interactions.Support development and implementation of novel analytics and metric models which provide flexible functional support for individual projects and our portfolio. This includes supporting the development and maintenance of models, simulations, and frameworks that drive the capacity and resource planning process for GRA’s portfolio. Additionally, assist in development of automated tools and templates to help manage and drive programs.  

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Bachelor’s Degree is required. Science, Engineering, Computer Science or business-related field preferred.5+ years pharmaceutical industry experience, with 3+ in Regulatory. Previous drug development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related function).Substantial experience working within Regulatory Affairs with a fluent understanding of drug development.Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environmentAbility to mentor and develop skills of team members; ability to articulate and establish business processes.Qualified project management experience; advanced expertise with project management related software and tools (i.e. MS Project, Sharepoint etc).Proven ability to communicate clearly and present key information objectively; demonstrated ability to clearly communicate/ prepare presentations for management.Analytical and Problem-Solving Skills - ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem.  Excellent ability to understand complex issues and propose creative and achievable solutions.Leadership Skills - ability to lead and motivate team members, without direct line management responsibility. Develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others (both inside and outside the department) towards the accomplishment of Takeda’s goals and objectivesStrategic Approach - identifies, create and implement processes for Regulatory Project Management that satisfy business objects of Takeda globally.Presentation skills – create and deliver presentations with appropriate messaging and focused recommendations.

PHYSICAL DEMANDS:

Routine demands of an office based environment.Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).Carrying, handling and reaching for objects. Ability to sit or stand for long periods of time while traveling.

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings, including overnight trips.Requires approximately up to 10-30% travel.