- Partners with the Global Regulatory Lead (GRL) on Global Regualtory Teams (GRTs) to ensure robust global program regulatory strategies for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.
- Expertly leads cross functional project teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex programs by providing expert and effective Project Mangement oversight, direction and planning.
- Leads both staff and teams. Utilizes robust project management methodologies and tools to identify, drive, track and deliver on key milestones/objectives for highly complex project programs and process related strategic initiatives for development, drug safety and regulatory projects. May lead key integration or process improvement initiatives
- Partner with the Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional major submission team meetings of high complexity, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy.
- Ensure Global Product Team (GPT) goals are cascaded and that Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
- Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables. Lead teams to identify and recommend solutions to problems and pathways to overcome barriers for strategy development and execution. Actively contribute to the development, implementation and continuous improvement of PM tools and processes for Global Regulatory Project Management (GRPM) and R&D.
- Maintain lessons learned log across project portfolios; detect, raise awareness and develop plan to address systemic concerns/issues.
- Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risk, mitigation management (and proposed solutions to support decision-making) across individual programs, and TAUs & BUs portfolios. Collaborate with the GRL in presenting strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.
- Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to management.
- Consult, support, advise and contribute to Takeda s body of Project Management Knowledge and Project Management processes.
- Provide leadership and manage multifaceted business critical projects and/or programs of very high complexity for departmental initiatives and workstreams as assigned.
- Oversee and mentor direct reports, providing leadership and training to support professional development.
- Supervise, coach, train, mentor and guide staff to excel in fulfilling all GRPM responsibilities. Oversee all direct report project and program deliverables, reporting, assignments and resources. Liaise and interface with third party stakeholders to ensure smooth and effective work flows.
- Responsible for demonstration of Takeda Leadership behaviors.
- Represents Takeda at industry forums regarding project and portfolio management is viewed internally/externally as an expert in the field.
CORE ELEMENTS RELATED TO THIS ROLE
- Superb Leadership, interpersonal, communication, supervisory, team building and negotiation skills
- Ability to drive teams towards solutions and options
- Ability to discern between critical and the non essential
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and drug development project management and regulatory affairs (e.g., clinical development, the prescription drug distribution process, etc)
- Demonstrated ability to work across functions, regions and cultures
- Functional level leadership with the ability to inspire, motivate and drive results
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can engender credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple comprehensible terms
- Demonstrates leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
- Invests time in helping others to enhance their skills and perform at a higher level
Decision-making and Autonomy
- Decision making responsibilities:
- Provide input to highly complex decisions that impact the functional area
- Accountable for decision making for designated function
- Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
- Accountable for providing input to and implementing vision and strategy for designated scope
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
- Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
- Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions
- Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
- Comfortable challenging the status quo and bringing forward innovative solutions
- Ability to take risks implementing innovative solutions, accelerating time to market
- Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
- Role models respect and inclusion, creating a culture that fosters innovation
- Ability to work in a global ecosystem (internal and external) with a high degree of complexity
- Deep expertise required
- Ability to see and understand broader, enterprise level perspective
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
- Bachelors of Science or Bachelor of Arts degree in a scientific discipline; advanced degree preferred
- 10 yrs pharma experience with 8 yrs regulatory or 10 yrs related field
- PMP certification or equivalent strongly preferred
- Additional certification a plus: Regulatory (e.g. RAC or equivalent), Change Management
- Demonstrated expert experience leading high performance teams, managing staff and mentoring colleagues.
- Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
- Proven ability to liaise with Regulatory Agencies having participated in Agency Interactions and industry forums, international experience preferred.
- Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
- Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.
- Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrates leadership, problem-solving ability, flexibility and teamwork.
- Exercises good judgement in elevating and communicating actual or potential issues to line management.
- Active participation in Agency/Industry groups/forums expected. Recognized as an expert in the field.
- Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging
- Excellent interpersonal and negotiation skills
- Demonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations
- Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.