The Manager, Regulatory Project Management (RPM) provides project management capabilities and leadership to the Global Regulatory Department to ensure the successful delivery of Regulatory projects and milestones for marketed programs of appropriate complexity.
- Works 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.
Utilizes 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. Acts as an expert in regulatory project management within the Takeda organization.
Strategic Planning and Execution
- The Manager, Regulatory Project Management (RPM) actively seeks and involves diverse team perspectives to shape regulatory strategy and drive decision-making.
- 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.
- Partners with Global Project Management (GPM) to ensure a seamless interface between Regulatory and the Global Project Team (GPT/EPT).
- Consolidates and maintains Global Regulatory project management information needed at the GPT/EPT.
- Maintains an integrated GRT deliverable projection for functional planning, in alignment with the GRSP.
- Escalates 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.
- Leads and manages GRTs in partnership with the GRL.
- With support from manager; drives project risk management processes and generates a cross-Regulatory risk register for assigned projects. Identifies project challenges, keeping leadership informed of critical considerations (e.g. resources, team health etc.)
- Consolidates and maintains Global Regulatory project management information needed at the Global Program Team (GPT); manages project status reporting to Senior Management and GPTs.
- Supports Global Regulatory strategic initiatives and Regulatory s involvement in related external projects; acts as the project lead where required (e.g. Product divestments and inlicensing, large-scale manufacturing site changes, process engineering, interface with GPM Project Management Office, etc.)
- Considers opportunities for continuous Regulatory process improvement across therapeutic areas and marketed products; ensures cross-Regulatory alignment on related issues.
- Plans, manages preparation for, and attends Regulatory Health Authority interactions.
Team Participation and Leadership
- Supports 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.
- Develops, communicates, and builds consensus around team goals.
- Identifies issues affecting team health and performance.
Alignment and CommunicationQualifications
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in a science or business-related field
- Substantial experience working within Regulatory Affairs with a fluent understanding of drug development
- Significant pharmaceutical industry experience
- Qualified project management experience
- Ability to articulate and establish business processes
- Experience multitasking in a dead-lined controlled and highly regulated environment
- Proven ability to communicate clearly and present key information objectively
- Master s Degree
- Degree in Regulatory Affairs or RA Certification
- Project Management certification
- Change management experience/Six Sigma
- 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.
- Communication Skills - ability to express one s self clearly and concisely to customers over the phone or with others within team; documents issues and/or concerns concisely and comprehensively.
- Politically astute and a confident and respectful motivator
- Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
- Knowledge Sharing - ability to capture knowledge within the organization; improve solutions, processes and deliverables through use of information; improve information capital by contributing experience, theories, deliverables and models for others to use. Shares information with staff as confidentiality allows
- Change Management ability to identify, advocate and implement change positively for the organization. Demonstrates flexibility and the ability to accommodate change.
- Teamwork - the ability to work well in a highly cross-functional team environment
- Leadership Skills - has the 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 objectives
- Strategic 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.
- Project Management Professional certification with PMI desired
- Six sigma certification desired
- Routine demands of an office based environment.
- International travel may be required in accordance with project team requirements
- Ability to attend offsite meetings that may involve overnight stay
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