Takeda
Associate Director, Global Regulatory Project Management and Strategic Planning
Takeda, Oklahoma City, Oklahoma, United States,
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. Key Responsibilities:
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. 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. 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:
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. 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. 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. Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management for assigned programs. 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. Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross-functional team members. Minimum Requirements/Qualifications:
Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred. Minimum of 8 years related experience, preferably with 4 years in Global Regulatory Affairs. Experience working on late-stage filings is highly preferred. Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process is required. Proven ability to provide regulatory operational support and guidance. Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging. 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. This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
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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. Key Responsibilities:
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. 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. 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:
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. 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. 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. Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management for assigned programs. 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. Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross-functional team members. Minimum Requirements/Qualifications:
Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred. Minimum of 8 years related experience, preferably with 4 years in Global Regulatory Affairs. Experience working on late-stage filings is highly preferred. Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process is required. Proven ability to provide regulatory operational support and guidance. Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging. 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. This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
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