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

Takeda•Boston, MA

4d•$154,400 - $242,550•Hybrid

About The Position

The Associate Director, Global Regulatory Project Management and Strategic Planning supports assigned programs within the Neuroscience Therapeutic Area Unit. In partnership with the program Global Regulatory Lead (GRL), this role co-leads Global Regulatory Team (GRT) meetings and submission working groups, translating regulatory strategy into operational plans and coordinating delivery of regulatory goals and submissions. The role aligns plans with Global Project Management, Therapeutic Area Units, and Business Units, and drives cross-functional teams to meet milestones and address barriers. The position oversees regulatory operational support, including coordination of vendors and third-party deliverables, health authority meeting logistics, regulatory document workflows, regulatory notifications, regulatory information system updates, and preparation and tracking of regulatory data. It provides milestone reporting, metrics, risk and issue escalation, decision-making support, and proposed mitigations to program stakeholders and management. The Associate Director also advances continuous improvement, identifies systemic bottlenecks, conducts lessons-learned activities, contributes to Takeda’s regulatory project management knowledge and processes, and trains or supports other regulatory project managers as needed. The role is expected to demonstrate Takeda leadership behaviors and work effectively across functions, regions, cultures, and external organizations.

Requirements

Bachelor’s degree required; an emphasis in science is preferred.
Ideal candidate has 8 years of related experience, preferably including 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 supplement) 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.
Ability to handle critical issues, provide regulatory operational advice, and make reasoned decisions on regulatory operational matters.
Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
Good judgment in elevating and communicating actual or potential issues to line management.
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 collaboratively lead without line authority and work effectively with other departments and external organizations.
Demonstrated experience leading decisions in cross-functional, cross-cultural global teams in a matrix environment.
Excellent organizational skills, ability to multitask, attention to detail, and ability to 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 identifying issues and opportunities and guiding 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 comprehensible terms.
Ability to build teams across functions and geographies and help others improve their skills and performance.
Ability to provide input to highly complex functional decisions and make decisions for the designated function.
Ability to seek input from diverse stakeholders, incorporate feedback, and ensure decisions are implemented effectively.
Ability to navigate changing internal and external environments, represent the function in negotiations, resolve conflict constructively, and build strong relationships.
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.
Science emphasis in undergraduate education preferred.
Four years of regulatory experience is preferred within the stated ideal profile of 8 years of related experience.

Responsibilities

Partner with the program 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 for complex programs.
Partner with the GRL to cascade Global Product Team regulatory goals and operationalize and execute the Global Regulatory Strategy Plan.
Align operational plans with Global Project Management and Therapeutic Area Unit and Business Unit asset strategies.
Drive GRT and submission working group teams, maintain urgency and focus on deliverables, and lead teams in identifying solutions to problems, 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, including outsourced deliverables and vendor timelines and standards.
Engage third-party stakeholders to support effective and timely workflows.
Coordinate operational activities such as forms and cover letters, health authority meeting logistics, briefing book roundtables, regulatory notifications, regulatory document workflows, regulatory information system updates, and regulatory data and lists.
Prepare and deliver reports and metrics on regulatory milestones, issues, constraints, bottlenecks, risks, mitigation plans, 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 processes and escalate issues as needed to support delivery of regulatory milestones.
Raise high-impact and business-critical issues, potential issues, and proposed actions to the GRL and management in a timely manner.
Recommend, plan, and implement process improvements through engagement with cross-functional teams and regulatory colleagues.
Identify systemic bottlenecks and constraints; conduct lessons-learned sessions, track project variances, identify root causes, and develop plans to address systemic issues.
Consult, support, advise, and contribute to Takeda’s regulatory project management knowledge and project management processes.
Provide training and support to other regulatory project managers as required.
Demonstrate Takeda Leadership behaviors.