Takeda · 2 months ago
Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology
Massachusetts - Virtual
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
8+ years expTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. The Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology will partner with the Global Regulatory Lead to ensure effective project management and regulatory operational support for oncology programs, driving successful submissions and regulatory strategies.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products are established and maintained, and plans & directs the seamless execution of the GRT goals
Leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase programs by providing 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
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
Qualification
Required
Bachelors degree required
Ideal candidate has a minimum of 8 yrs related experience (e.g. Regulatory Project Management), preferably with 4 Yrs. In Global Regulatory Affairs
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required
At least two major eCTD (original or supplement) registrations and several minor (amendment) filing experiences in the USA or more jurisdictions
Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support is needed
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 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
Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment
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
Expertise with project management related software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc)
Preferred
Emphasis in Science preferred
Advanced degree preferred
Experience working on late stage filings is highly preferred
Advanced education or credentialing in regulatory affairs and project management preferred
Demonstrated expert experience leading high performance teams and mentoring colleagues
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-19
2026-01-14
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