![]() ![]() Ensure out-sourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards. Provide and oversee regulatory operational support activities for assigned programs within the TAU.Develop and maintain integrated regulatory project plans and integrated SWG plans. Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. Proactively drive GRT and SWG project teams, establish appropriate level of urgency, and maintain focus on deliverables.Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies. 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.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 complex programs.Performs regulatory operational activities and directly oversees vendors providing operational support for assigned programs. Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations.Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning.Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. ![]() We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We are united by our four priorities (patient, trust, reputation and business) and Takeda-ism (Integrity, Fairness, Honesty and Perseverance), and strive towards better health and a brighter future for people worldwide.Īt Takeda, we empower our people to realize their potential through life-changing work. Today, we are the number one pharmaceutical company in Japan and a global industry leader, with approximately 50,000 employees around the world. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives. Takeda is unwavering in our commitment to patients. I further attest that all information I submit in my employment application is true to the best of my knowledge.Īre 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, based remotely. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. ![]()
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