The Associate Director, Regulatory Project Management (RPM) is a member of a high-profile Regulatory Affairs Vaccines team advancing a program of strategic importance to Takeda. You will play the role of Regulatory Chief Operating Officer of the project, leading strategic planning and execution.
- Leads Global RPM activities in predicting and planning solutions to achieve operational excellence; driving cross-functional 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 Program Lead (GRPL), as well as members of other Regulatory and/or GPT (Global Program Team) sub-groups, to ensure that the Regulatory development strategy is translated into an efficient, executable operational plan.
- Works closely with the GRPL and Regulatory Affairs Vaccines Regional Heads to build a truly global registration plan.
- Expert at project management methodologies and tools; identifies and drives strategic initiatives such as process improvements and/or departmental projects.
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 others.
Strategic Planning and Execution
- The Associate Director, Regulatory Project Management (RPM) leads the project planning efforts of the global regulatory team in the definition and implementation of the global regulatory plan as well as the operational plan and execution strategies with the team; obtains buy-in of all team members and maintains the plan.
- 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 Global Regulatory Team (GRT) if instituted or regulatory colleagues, including risks and issues that may impact the project; engages appropriate representatives to manage outcomes. Follows issues through to resolution, ensuring that all regulatory issues arrive at a conclusion or recommendation.
- Leads and manages GRTs in partnership with the GRPL; drives key decisions and ensures project execution.
- Maintains an integrated, deliverable projection for functional planning, in alignment with the global regulatory functional plan.
- 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 may attend, as assigned, 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)
- 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 Communication
- Regularly informs GRA leadership of important timely issues and impact on the global program, as well as meaningful metrics for regulatory deliverables and performance.
- Encourages collaboration and communication globally across Regulatory and between regional representatives in the team ensuring that team goals are achieved.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in a science or business-related field; advanced degree preferred
- 8+ years pharmaceutical industry experience, with 6+ in Regulatory. Previous vaccine development experience is preferred (e.g. Regulatory, Clinical, CMC, or other development related function)
- 5+ years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment
- Substantial experience working within Regulatory Affairs with a fluent understanding of product development, prior experience with development of vaccines or biologics is preferred but not required
- 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
- Advanced Degree
- 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, across time zones
- 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 and dashboards 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; approximately 20% travel
- Ability to attend offsite meetings that may involve overnight stay
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.