- This position works within the organization to advance the objectives and vision of the Head of Global Regulatory Affairs Vaccines. Will work independently with the management team to solve problems and address issues before they escalate, when possible. This position is intended to increase experience of the management team as a whole, as well as their ability to deliver on expected results, interacting across multiple functional areas and, ultimately, increase interdepartmental efficiencies.
- Responsible for developing and ensuring execution of strategic plans, projects and commitments which drive top and bottom line growth. Develops and executes analytical and tactical strategies to ensure business projects, milestones and policies are completed in a timely manner.
- Develop, lead and oversee the Vaccines global RA Quality Management System and processes, regulatory communication and change management strategy, strategic initiatives, overall planning and regulatory metrics, in line with Takeda corporate and GRA as appropriate.
- Lead Vaccines RA Project Management to ensure Regulatory Team deliverables and delivered in line with Global Project Team and business needs.
- Primary interface with external vendor partnership(s) at an organizational level, managing RA specific relationships and developing trusted partnerships, monitoring RA specific performance indicators, facilitating regulatory issue resolution, regulatory planning and regulatory compliance being delivered by the external partner(s).
- Monitor progress toward Vaccines RA s KPIs, intervening as necessary to ensure that Global Regulatory Affairs (GRA) is on track to meet or exceed its performance targets. Provides complex analysis and insight in evaluating overall GRA performance over time and for future planning.
- Serve as a member of the Vaccines RA Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.
- Serve as a strategic thought partner to the Head GRA Vaccines with regard to complex problems, current and future initiatives, strategies, and budgets. Looks across Vaccines RA functions to identify synergies and interdependencies to ensure optimal working model across all regulatory sites/functions.
- Develop and maintain an RA Quality Management System including a system for providing appropriate worldwide training.
- Build and maintain communication strategy and platform for all RA staff across the organization.
- Optimize Global RA Project Management to fully support Global Regulatory Teams.
- Build and maintain RA labeling system, working closely with PV to meet current and future business needs.
- Oversee overall Regulatory specific partnership with external provider(s). Ensure partner, planning and compliance elements are in line with Takeda business and compliance obligations. Work closely with PV organization to ensure RIM and Labeling elements are provided in timely manner.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Minimum BS/BA degree with advanced scientific degree preferred.
- Minimum of 15 years of industry experience with majority in drug development related areas. Project management experience is preferred.
- Demonstrated knowledge and understanding of global drug development and interface with commercial organization
- Experience in operating in a multi-disciplinary drug development environment, including working within and managing across an international exposure
- Experience working within complex organizations, working closely with senior staff and executive level colleagues. The ideal candidate will have the acumen to handle complex situations and multiple responsibilities simultaneously mixing long term projects with the urgency of immediate demands on the operations. S/he must also have the demonstrated ability to deal with highly confidential information and act as a liaison between Head of GRA Vaccines and other senior level incumbents.
- Demonstrated ability to collaborate with and achieve actionable results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.
- Energetic, smart, and hands-on self-starter with a desire to learn new things quickly. Proven ability to refine and improve the organization s capabilities. Demonstrated track record to effectively handle key organizational matters. Must be able to exhibit diplomacy with all constituents and represent the changing face of the organization both internally and externally. Demonstrated track record to proactively identify, assess, and analyze scenarios that may affect operations, and a proven history of taking an institutional perspective.
- Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Proven ability to proactively identify and lead the development and re-engineering of key processes and systems in support of the business mission.
- Proven record of innovative and independent problem-solving skills, combined with excellent communication, interpersonal, and managerial skills. Ability to work independently and collaboratively, strong leadership and organizational skills, and able to drive multiple projects to successful, timely completion in a fast-paced, entrepreneurial environment.
- Outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.
- Ability to use appropriate judgment in maintaining confidentiality of information. Must possess excellent presentation and communication skills, both oral and written. Strong professional writing skills a must.
- Must be able to effectively multi-task, prioritize, meet deadlines, and manage critical issues in a dynamic environment. Ability to manage multiple projects concurrently and manage a large volume of details while maintaining a big-picture perspective.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to top management, internal groups, external stakeholders and customers.
- Approximately 15-20% domestic and international travel.
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