OBJECTIVES/PURPOSE

Partners with the Global Regulatory Lead (GRL) on Global Regualtory Teams (GRTs) to ensure robust global program regulatory strategies for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.Expertly leads cross functional project teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective Project Mangement oversight, direction and planning.Leads both staff and teams. Utilizes robust project management methodologies and tools to identify, drive, track and deliver on key milestones/objectives for highly complex project programs and process related strategic initiatives for development, drug safety and regulatory projects.  May lead key integration or process improvement initiatives

ACCOUNTABILITIES

Partner with the Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional major submission team meetings of high complexity, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy.Ensure Global Product Team (GPT) goals are cascaded and that Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables. Lead teams to identify and recommend solutions to problems and pathways to overcome barriers for strategy development and execution. Actively contribute to the development, implementation and continuous improvement of PM tools and processes for Global Regulatory Project Management (GRPM) and R&D.Maintain lessons learned log across project portfolios; detect, raise awareness and develop plan to address systemic concerns/issues.Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risk, mitigation management (and proposed solutions to support decision-making) across individual programs, and TAUs & BUs portfolios. Collaborate with the GRL in presenting strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to management. Consult, support, advise and contribute to Takeda’s body of Project Management Knowledge and Project Management processes.Provide leadership and manage multifaceted business critical projects and/or programs of  very high complexity for departmental initiatives and workstreams as assigned.  Oversee and mentor direct reports, providing leadership and training to support professional development.Supervise, coach, train, mentor and guide staff to excel in fulfilling all GRPM responsibilities. Oversee all direct report project and program deliverables, reporting, assignments and resources. Liaise and interface with third party stakeholders to ensure smooth and effective work flows.Responsible for demonstration of Takeda Leadership behaviors.Represents Takeda at industry forums regarding project and portfolio  management is viewed internally/externally as an expert in the field.

CORE ELEMENTS RELATED TO THIS ROLE

Superb Leadership, interpersonal, communication, supervisory, team building and negotiation skillsAbility to drive teams towards solutions and optionsAbility to discern between critical and the non essential

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Comprehensive understanding of the pharmaceutical industry and  drug development project management and regulatory affairs  (e.g., clinical development, the prescription drug distribution process, etc)

Leadership

Demonstrated ability to work across functions, regions and culturesFunctional level leadership with the ability to inspire, motivate and drive resultsExcellent communicator, able to persuasively convey both ideas and data, verbally and in writingProven skills as an effective team player who can engender credibility and confidence within and outside the companyAbility to distil complex issues and ideas down to simple comprehensible termsDemonstrates leadership presence and confidenceEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizationBuilds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

Decision making responsibilities: Provide input to highly complex decisions that impact the functional areaAccountable for decision making for designated functionAbility to seek diverse input from multiple constituents and stakeholders to drive innovative solutionsAbility to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution  Accountable for providing input to and implementing vision and strategy for designated scope

Interaction

Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplaceCultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.Effectively represents function in negotiations with the ability to resolve conflict in a constructive mannerAbility to build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovationComfortable challenging the status quo and bringing forward innovative solutionsAbility to take risks implementing innovative solutions, accelerating time to marketIdentifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.Role models respect and inclusion, creating a culture that fosters innovation

Complexity

Ability to work in a global ecosystem (internal and external) with a high degree of complexityDeep expertise requiredAbility to see and understand broader, enterprise level perspective 

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS

Bachelors of Science or Bachelor of Arts degree in a scientific discipline; advanced degree preferred10 yrs pharma experience with 8 yrs regulatory or 10 yrs related fieldPMP certification or equivalent strongly preferredAdditional certification a plus: Regulatory (e.g. RAC or equivalent), Change ManagementDemonstrated expert experience leading high performance teams, managing staff and mentoring colleagues.Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.Proven ability to liaise with Regulatory Agencies having participated in Agency Interactions and industry forums, international experience preferred.Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support. Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.Demonstrates leadership, problem-solving ability, flexibility and teamwork.Exercises good judgement in elevating and communicating actual or potential issues to line management.       Active participation in Agency/Industry groups/forums expected. Recognized as an expert in the field.Excellent verbal and written communication skills and ability to prepare effective presentations with focused messagingExcellent interpersonal and negotiation skillsDemonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizationsExcellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelinesAbility to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusionsAnalytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.