Associate Director, Global Regulatory Project Management and Strategic Planning - GI²

Takeda Pharmaceutical Company • Juneau, AK

436d

About The Position

The Associate Director, Global Regulatory Project Management and Strategic Planning at Takeda Pharmaceuticals is a pivotal role within the Global Regulatory Affairs organization. This position focuses on leading cross-functional teams to ensure the successful execution of regulatory project plans for various programs and products. The role emphasizes collaboration with the Global Regulatory Lead and involves overseeing regulatory submissions, managing operational support, and driving continuous improvement in regulatory processes.

Requirements

• Bachelor's degree required, with an emphasis in Science preferred; advanced degree preferred.
• Minimum of 8 years related experience in Regulatory Project Management, with at least 4 years in Global Regulatory Affairs.
• Experience with late-stage filings is highly preferred.
• Advanced education or credentialing in regulatory affairs and project management preferred.
• Significant experience in global drug development regulations and regulatory submissions is required.
• Experience with at least two major eCTD registrations and several minor filings in the USA or other jurisdictions.
• Understanding of scientific principles and regulatory standards relevant to global drug development is needed.
• Proven ability to provide regulatory operational support and guidance.

Nice To Haves

• Experience in leading high-performance teams and mentoring colleagues.
• Active participation in industry groups/forums is expected.
• Expertise with project management software and tools such as MS Project, OnePager, and SharePoint.

Responsibilities

• Partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to establish and maintain global regulatory project plans.
• Lead cross-functional project submission working groups (SWG) to ensure successful submissions and outcomes with Health Authorities (HA).
• Support the GRL by providing effective project management and regulatory operational support for assigned programs.
• Co-lead and facilitate product-specific GRT meetings and SWG meetings to oversee and deliver regulatory submissions.
• Ensure alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs).
• Drive project teams to maintain focus on deliverables and identify solutions to overcome barriers.
• Provide oversight for regulatory operational support activities and ensure third-party deliverables meet timelines and standards.
• Prepare and deliver reports on regulatory milestone status and potential issues to key stakeholders.
• Drive decision-making processes and escalate issues as needed to ensure delivery of regulatory milestones.
• Recommend and implement process changes to improve efficiency and address systemic bottlenecks.

Benefits

• Health insurance
• 401k
• Paid holidays
• Professional development opportunities
• Flexible scheduling

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree