The Head, Regulatory Project Management & Strategic Planning (RPM/SP) provides regulatory program/project management and strategic planning leadership to the GRA organization. The Head, RPM/SP will create the new RPM department and work with Head of GRA Organizational Operations & Compliance to identify and deliver regulatory project management for critical, high value programs in the R&D portfolio, aligning business needs and regulatory support to achieve program/project and business objectives. S/he will participate in the development of short to long range strategic organizational planning for the GRA business and leads key team members/teams in establishing and executing upon GRA Road Map strategic and initiatives.
The Head, RPM/SP is a senior member of the Global Regulatory Affairs department and is of strategic importance to Takeda, leading and developing a group in refining regulatory strategic planning and operational execution for projects typically in late-stage development (starting at PoC), or on the market, with complex international activities and regulatory scenarios.
- Partners with RA Therapeutic Area (TA) Leaders to ensure overall GRA alignment and delivery of results to realize the project/program/department vision, mission and strategy
- Collaborates with RA TA Leader, as well as members of other Regulatory sub-groups and Global Regulatory Teams (GRT), to ensure that the Regulatory development strategy is translated into efficient, executable operational plans.
- Develops, tracks, and optimizes communication strategies, metrics, and provides oversight and support to GRA RPM s. Responsible for overall RPM and Strategic Planning Department strategy/es, and resourcing needs to meet defined departmental and project objectives and partnership delivery priorities.
- Expert at project management methodologies and tools; identifies and drives strategic initiatives, such as process improvements and/or departmental projects. Proactively utilizes data and predictive metrics to improve the project execution and meet GRA s portfolio/organizational objectives.
- Develops tools, reports, templates, business processes, and communications to identify opportunities and creates mechanisms for driving future improvement.
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 and strategic planning; acts as an expert within the Takeda organization and in a mentoring capacity to team members.
Strategic Planning and Execution
- Responsible for ensuring that the regulatory project management team s strategies and operational plans align with the project/program objectives and that the RPMs are developed in leadership and operational techniques to add value to the GRTs.
- Leads the RPM/SP department risk/issue management process and Monthly GRA Reviews to identify and proactively remediate issues.
- 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 and strategic plans/metrics/data needed at the GRT and GRA departmental level; manages regulatory project status reporting to Senior Regulatory Management and GRTs, including scheduled and ad-hoc updates.
- Works with and through team members to proactively identify and recommend solutions for any systemic project/system concerns or obstacles, including risks and issues that may impact projects; engages appropriate representatives to manage outcomes. Follows issues through to resolution, ensuring that RPMs are supported and able to address all GRT issues in a timely manner.
- Creates, tracks, and reports on key GRA Road Map strategies and initiatives to drive business process best practices, improve overall GRA planning and execution, and develop mechanisms to communicate improvements and next initiatives to move organization towards GRA Vision.
- Leads Global Regulatory strategic initiatives and/or Regulatory s involvement in related external projects; acts 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.)
- 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.
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; knowledge of pharmaceutical industry.
- Qualified project management experience; advanced expertise with project management related software and tools (i.e. MS Project, Sharepoint etc)
- Demonstrated strategic problem-solving ability.
- Demonstrated ability to clearly and concisely communicate with and prepare presentations for Senior Management and Executives.
- Solid business background as well as excellent commercial understanding
- Highly effective written and verbal communication skills in order to manage, motivate and drive decisions within cross-cultural teams.
- Proven skills in negotiation, influencing without authority and working diplomatically through conflict.
- Proven people management skills. Experience should include managing mid- to- senior level employees.
- Sufficient technical knowledge in order to determine how project data can be organized meaningfully in order to facilitate Senior Management and Executive decision processes.
- Sufficient knowledge of all MS Office tools in order to be able to effectively capture and communicate project information.
- 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
- RAC 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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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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