The Associate Director, Regulatory Project Management (RPM) is a senior member of a high-profile project team of strategic importance to Takeda, plays the role of Regulatory Chief Operating Officer of the project, leading strategic planning and execution. The project will typically be in late-stage development (starting at PoC) or on the market, with complex international activities and regulatory scenarios.
This position will ensure that Takeda is aware and responsive to external guidelines, changes in the marketplace and other information relating to global regulatory project management; acts as an expert in regulatory project management within the Takeda organization and in a mentoring capacity to the Regulatory Project Managers.
- Leads Regulatory teams in predicting and planning solutions to achieve operational excellence; driving teams to achieve clarity on issues, interfacing with senior management and supporting decision-making, while monitoring timelines and developing strategies to stay on schedule and navigating through the internal Regulatory and Global Program Team governance for projects.
- Partners with the Global Regulatory Lead (GRL), as well as members of other Regulatory sub-groups, to ensure that the Regulatory development strategy is translated into an efficient, executable operational plan.
- Expert at project management methodologies and tools; identifies and drives strategic initiatives such as process improvements and/or departmental projects.
Strategic Planning and Execution
- The Associate Director, Regulatory Project Management (RPM) leads 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.
- Actively seeks and involves diverse team perspectives to shape regulatory strategy and drive decision-making.
- Ensures operational plans are driven by and aligned to the global asset strategy; partners with Global Project Management (GPM) to ensure a seamless interface between Regulatory and the Global Project Team (GPT).
- Orchestrates and maintains Global Regulatory project management information needed at the GPT; manages project status reporting to Senior Management and GPTs, including scheduled and ad-hoc updates.
- Proactively identifies and recommends solutions for any timeline concerns or obstacles to the GRT, including risks and issues that may impact the project; 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; drives key decisions and ensures project execution.
- Maintains an integrated GRT deliverable projection for functional planning, in alignment with the GRSP.
- Responsible for coordinating governance approvals for key project deliverables.
- Leads project risk management processes and generates a cross-Regulatory risk register for assigned projects. Addresses and resolves project challenges, keeping leadership informed of critical considerations (e.g. resources, team health etc.)
- Leads 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.)
- Identifies and leads innovative process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management processes and systems.
- Develops and leads training sessions on specific technical topics related to planning tools and systems.
- Plans, manages preparation for, and attends Regulatory Health Authority interactions.
- May support Business Development activities.
- Collaborates with the global project management operation in support of further developing project management capabilities across the organization.
Team Participation and Leadership
- Partners with 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.
- Directs and mentors junior colleagues in working strategically and driving for results; helps them break down problems into manageable pieces; looks for opportunities for junior RPMs to demonstrate their abilities to larger audiences; uses effective coaching techniques to refocus energy and address frustrations; leads by example (e.g. maintains composure under pressure)
- May have line management responsibility within the RPM function.
- Develops, communicates, and builds consensus around team goals.
- Identifies and moves to resolve issues affecting team health and performance.
- Leads initiatives to develop, improve and implement RPM operational standards.
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
- Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment
- Ability 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 leadership skills and strategic problem-solving ability
- Proven ability to communicate clearly and present key information objectively; demonstrated ability to clearly communicate/ prepare presentations for management
- Master s Degree
- Degree in Regulatory Affairs or RA Certification
- Project Management certification
- Change management experience/Six Sigma
- 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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