Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience TAU

Takeda•Boston, MA

2d•Hybrid

About The Position

The Associate Director partners with the program Global Regulatory Lead (GRL) to co-lead product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWGs), planning and delivering regulatory goals and submissions in alignment with regulatory strategy. The role helps operationalize the Global Regulatory Strategy Plan, align regulatory plans with Global Project Management and Therapeutic Area Unit (TAU) or Business Unit (BU) strategies, and maintain focus on deliverables across complex programs. The position develops and maintains integrated regulatory and submission working group project plans, oversees operational support for assigned programs, and ensures third-party and vendor deliverables meet timelines and company standards. Operational activities may include preparing forms, cover letters and notifications; supporting health authority meetings and briefing book roundtables; managing regulatory document workflows and information systems; and preparing, checking and tracking regulatory data and lists. The Associate Director reports on milestones, risks, constraints and mitigation plans; supports stakeholder updates and decision-making; escalates critical issues; and leads continuous improvement, lessons learned and root-cause analysis. The role also contributes to Takeda’s regulatory project management practices and knowledge base, and provides training and support to other regulatory project managers. The position is classified as hybrid under Takeda’s Hybrid and Remote Work policy.

Requirements

Bachelor’s degree required; emphasis in science preferred.
Minimum of 8 years of related experience; the ideal candidate has at least 4 years in regulatory affairs.
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and processes.
Experience with at least one major original or supplemental filing and several minor amendment filings in one or more jurisdictions, including eCTD experience.
Understanding of scientific principles and regulatory standards and requirements relevant to global drug development and post-market support.
Proven ability to provide regulatory operational support and guidance, address critical issues, offer operational advice and make reasoned decisions.
Demonstrated expert experience leading high-performance teams and mentoring colleagues.
Leadership, problem-solving, flexibility and teamwork skills, with sound judgment in communicating and escalating actual or potential issues.
Active participation in industry groups or forums expected.
Excellent verbal and written communication skills, including the ability to prepare effective presentations with focused messaging.
Excellent interpersonal and negotiation skills.
Ability to lead collaboratively without line authority and work effectively with internal departments and external organizations.
Experience leading decision-making in cross-functional, cross-cultural global teams in a matrix environment.
Strong organizational skills, attention to detail and ability to multitask and manage multiple projects within assigned timelines.
Ability to apply scientific principles, collect and analyze relevant information, establish facts and draw valid conclusions.
Analytical and problem-solving skills, including the ability to identify issues and opportunities and guide teams in exploring alternatives.
Expertise with project management software and tools such as Planisware, Microsoft Project, OnePager, Office Timeline and SharePoint.
Comprehensive understanding of the pharmaceutical industry, drug development project management and regulatory affairs.
Ability to work across functions, regions and cultures and inspire, motivate and drive results.
Ability to communicate ideas and data persuasively, build credibility and confidence, and distill complex issues into clear terms.
Ability to build teams across functions and geographies and invest time in helping others develop their skills.
Ability to seek diverse input, incorporate feedback, make decisions and support swift implementation.
Ability to navigate change, cultivate broad internal and external networks, represent the function in negotiations, resolve conflict constructively and collaborate across Takeda functions.
Forward-thinking approach to organizational change and continuous innovation, including willingness to challenge the status quo and implement innovative solutions.
Ability to work in a complex global ecosystem and understand the broader enterprise perspective.

Nice To Haves

Advanced degree preferred.
Advanced education or credentialing in regulatory affairs and project management preferred.

Responsibilities

Partner with the Global Regulatory Lead to co-lead and facilitate product-specific Global Regulatory Team meetings and cross-functional submission working group meetings.
Oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy.
Help cascade Global Product Team regulatory goals and operationalize and execute the Global Regulatory Strategy Plan.
Align regulatory operational plans with Global Project Management and TAU or Business Unit asset strategies.
Drive GRT and submission working group teams, establish urgency and maintain focus on deliverables.
Lead teams in identifying solutions to problems and pathways to overcome timeline concerns and barriers to strategy execution.
Develop and maintain integrated regulatory project plans and submission working group plans.
Provide and oversee regulatory operational support for assigned programs within the TAU.
Ensure outsourced regulatory operational deliverables from third parties and vendors meet program timelines and company standards.
Engage third-party stakeholders to support smooth, effective and timely workflows.
Support operational activities such as preparing forms, cover letters and regulatory notifications; arranging health authority meetings and briefing book roundtables; managing document workflows; entering information into regulatory information management systems; and preparing, checking and tracking regulatory data and lists.
Prepare and deliver reports and metrics on milestone status, critical issues, constraints, bottlenecks, regulatory risks, mitigation management and proposed solutions.
Collaborate with the GRL to present operational strategies and plan status to stakeholders through scheduled and ad hoc updates.
Drive decision-making and escalate issues as needed to enable delivery of regulatory milestones.
Timely elevate high-impact and business-critical issues, potential issues and proposed action plans to the GRL and management.
Recommend, plan and implement process improvements through engagement with cross-functional teams, Global Regulatory Affairs TAU colleagues and the RPM&SP head.
Identify and propose solutions to systemic bottlenecks and constraints.
Conduct lessons-learned sessions, track project variances, identify root causes and develop plans to address systemic concerns.
Contribute to Takeda’s regulatory project management knowledge and processes, and train and support other regulatory project managers as required.
Demonstrate Takeda Leadership behaviors.