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

Takeda Pharmaceutical Company - Trenton, NJ

Full-time - Mid Level

Trenton, NJ

Chemical Manufacturing

About the position

The Associate Director, Global Regulatory Project Management and Strategic Planning - GI at Takeda Pharmaceuticals is a pivotal role within the Global Regulatory Affairs organization. This position focuses on ensuring the effective management and execution of global regulatory project plans for various programs and products. The role involves collaboration with cross-functional teams to facilitate successful submissions to health authorities, thereby contributing to the delivery of transformative therapies to patients worldwide.

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 program GRL by providing effective project management and regulatory operational support for assigned assets.
• Oversee vendors providing operational support for regulatory activities.
• Facilitate product-specific GRT meetings and SWG meetings to deliver regulatory submissions in line with strategy.
• Drive project teams to maintain focus on deliverables and identify solutions to overcome barriers.
• Develop and maintain integrated regulatory project plans and SWG plans.
• Prepare and deliver reports on regulatory milestone status and potential issues.

Requirements

• Experience in regulatory project management within the pharmaceutical industry.
• Strong leadership and communication skills to manage cross-functional teams.
• Ability to develop and maintain project plans and timelines.
• Experience in preparing regulatory submissions and liaising with health authorities.

Nice-to-haves

• Experience with early to late phase programs in regulatory affairs.
• Familiarity with regulatory information management systems.
• Project management certification or training.

Benefits

• Comprehensive health insurance coverage.
• 401k retirement savings plan with company matching contributions.
• Paid time off and holidays.
• Professional development opportunities.