What are the responsibilities and job description for the Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience position at Takeda Pharmaceuticals?
Takeda Pharmaceuticals Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience Honolulu, Hawaii Apply Now Job DescriptionAbout the role : At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. 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 - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely.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.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.Proactively drive GRT and SWG project teams, establish appropriate level of urgency, and maintain focus on deliverables.Provide and oversee regulatory operational support activities for assigned programs within the TAU.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.Drive continuous improvement by recommending, planning and implementing process changes.Minimum Requirements / Qualifications : Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred.Minimum of 8 years related experience (e.g. Regulatory Project Management), preferably with 4 years in Global Regulatory Affairs.Experience working on late stage filings is highly preferred.Advanced education or credentialing in regulatory affairs and project management preferred.Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.At least two major eCTD (original or supplement) registrations and several minor (amendment) filing experiences in the USA or more jurisdictions.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.#J-18808-Ljbffr
