Associate Director, Global Regulatory Project Management and Strategic Planning

Job Description
About the Role
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning – GI² TAU within our Global Regulatory Affairs organization, based remotely.

Partnership: 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.

Leadership: 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.

Support: 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.

How You Will Contribute
Team Facilitation: 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 moderately complex programs and submissions.

Strategic Alignment: 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.

Project Driving: 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.

Operational Oversight: 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 workflows.

Reporting & Metrics: Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, and mitigation management for assigned programs. Collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders.

Decision Making: 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.

Continuous Improvement: Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross-functional team members. Conduct lessons learned sessions for assigned programs; track project variances and identify root causes.

Mentorship: Consult, support, advise and contribute to Takeda’s body of Regulatory Project Management Knowledge and processes. Provide training and support to other RPMs as required.

Minimum Requirements/Qualifications
Education: Bachelor’s degree required (Science emphasis preferred). Advanced degree preferred.

Experience: Ideal candidate has a minimum of 8 years related experience (e.g., Regulatory Project Management), preferably with 4 years in Global Regulatory Affairs.

Filing Expertise: Experience working on late-stage filings is highly preferred. At least two major eCTD (original or supplement) registrations and several minor filing experiences in the USA or more jurisdictions.

Regulatory Knowledge: Significant experience in global drug development regulations, regulatory submissions, lifecycle management, and compliance is required.

Leadership Skills: Proven ability to provide regulatory operational support and guidance. Demonstrates leadership, problem-solving ability, flexibility, and teamwork.

Communication: Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.

Soft Skills: Excellent interpersonal and negotiation skills. Demonstrated experience in leading decision-making within a cross-functional, global team structure in a matrix environment.

Technical Proficiency: Expertise with project management related software and tools (e.g., MS Project, OnePager, Office Timeline, SharePoint, etc.).

More About Us
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

Apply here