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.Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning.Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations. Performs regulatory operational activities and directly oversees vendors providing operational support for assigned programs.ACCOUNTABILITIES
Partnering with the program 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 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. Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. Develop and maintain integrated regulatory project plans and integrated SWG plans.Provide and oversee regulatory operational support activities for assigned programs within 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, preparing, checking and tracking regulatory data and lists 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) for assigned programs. 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 for assigned programs.Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management. Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose solutions for addressing potential systemic bottlenecks and constraints. Conduct lessons learned sessions for assigned programs; 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.Provide training and support to other RPMs as required.Responsible for demonstration of Takeda Leadership behaviors.EDUCATION, BEHAVIORAL, COMPETENCIES AND SKILLS
Bachelors degree required. Emphasis in Science preferred. Advanced degree preferredIdeal candidate has 8 yrs related experience, preferably with 4 yrs in regulatoryAdvanced education or credentialing in regulatory affairs and project management preferredDemonstrated expert experience leading high performance teams and mentoring colleagues.Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.At least one 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.Excellent verbal and written communication skills and ability to prepare effective presentations with focused messagingExcellent interpersonal and negotiation skillsDemonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations. Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environmentExcellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelinesAbility to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts and draw valid conclusionsAnalytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.Expertise with project management related software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc).EEO Statement
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.
Massachusetts - Virtual Worker Type
RegularTime Type Full time