- Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU)
- Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning.
- Directly supports TAU Regulatory Head by ensuring project management and regulatory operational support for the therapeutic areas product portfolio is effective, seamless and delivering to expectations. Generates and delivers reports on portfolio metrics and status updates with actionable insights. .
- Partner with the Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings , to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for highly complex programs.
- Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded and that the 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 GRT and SWG 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 execution. Develop and maintain integrated regulatory project plans and integrated SWG plans.
- Directly support TAU Regulatory head with portfolio analytics by creating, leading and delivering actionable assessment reports and updates, as well as efficient processes for portfolio status reviews. Provide project management support for TAU GRA department meetings and project management leadership for business critical projects and/or programs of very high complexity for TAU GRA specific initiatives and workstreams as required/requested.
- Provide and oversee regulatory operational support activities for programs supported by the TAU. Ensure out-sourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards. Liaise and proactively engage with third party stakeholders to ensure smooth, effective and timely work flows. Operational support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support for health authority meetings, coordinating briefing book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems etc.)
- Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) across individual programs, and across the TAU portfolio, as required. Collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.
- Drive decision making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones across the TAUs portfolio of projects.
- Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to management.
- Drive continuous improvement across TAU GRTs by planning and implementing changes through proactive engagements with GRA TAU head. Identify and propose solutions for addressing potential systemic bottlenecks and constraints across the portfolio.
- Supervise, coach and mentor staff. Provide leadership and training to support Regulatory Project Managers’ abilities to deliver on all expectations and their professional development
- Actively contribute to the development, implementation and continuous improvement of PM tools and processes for Global Regulatory Project Management and Strategic Planning (RPM&SP). Maintain lessons learned log across project portfolios; track project variances and identify root causes; detect, raise awareness and develop plan to address systemic concerns/issues.
- Consult, support, advise and contribute to Takeda’s body of Regulatory Project Management Knowledge and Project Management processes.
- Responsible for demonstration of Takeda Leadership behaviors.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors degree required, emphasis in Science preferred. Advanced degree preferred
- 10 yrs pharma experience with 8 yrs regulatory or 10 yrs related field preferred
- 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.
- At least 2 major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is required.
- Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
- Proven ability to provide regulatory operational support and guidance.
- Able to deal with issues of critical importance, provides regulatory operational advice and making reasoned decisions on regulatory operational issues.
- 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 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 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.
“This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.”
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.Locations
Massachusetts - VirtualWorker Type