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Senior Director, Global Regulatory Project Management, GI ² - Honolulu, HI, United States - Takeda Pharmaceuticals
Description
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 .
I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Join us as a Senior Director, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely.
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.
Oversees and provides regulatory operational support for programs in the GI2 Therapeutic Area Unit (TAU)Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning.
Directly supports GI 2 TAU Regulatory Head by ensuring project management and regulatory operational support for the therapeutic areas product portfolio is effective, seamless and delivering to expectations.
Partner with the 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 highly complex programs.
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.
Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
Proactively drive GRT and SWG project teams, establish appropriate level of urgency, and maintain focus on deliverables. Develop and maintain integrated regulatory project plans and integrated SWG plans.Directly support TAU Regulatory head with portfolio analytics by creating, leading and delivering actionable assessment reports and updates, as well as efficient processes for portfolio status reviews.
Provide project management support for TAU GRA department meetings and project management leadership for business critical projects and/or programs of very high complexity for TAU GRA specific initiatives and workstreams as required/requested.
Provide and oversee regulatory operational support activities for programs supported by the TAU. Ensure out-sourced regulatory operational deliverables by third parties and vendors meet all program timelines and company standards.Operational support may include, but not limited to drafting and preparation of forms and cover letters, providing logistical support for health authority meetings, coordinating briefing book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems etc.)
Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, mitigation management (and proposed solutions to support decision-making) across individual programs, and across the TAU portfolio, as required.
GPT members, Regulatory Leadership. TAUs & BUs) as appropriate, through both scheduled and ad-hoc updates.Drive decision making processes and escalate issues, as needed, ensuring proactive planning is taking place to enable delivery of all regulatory milestones across the TAUs portfolio of projects.
Elevate high impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to management.
Drive continuous improvement across TAU GRTs by planning and implementing changes through proactive engagements with GRA TAU head. Supervise, coach and mentor staff. Provide leadership and training to support Regulatory Project Managers' abilities to deliver on all expectations and their professional developmentActively contribute to the development, implementation and continuous improvement of PM tools and processes for Global Regulatory Project Management and Strategic Planning (RPM&SP).
Maintain lessons learned log across project portfolios; track project variances and identify root causes; Consult, support, advise and contribute to Takeda's body of Regulatory Project Management Knowledge and Project Management processes.
Comprehensive understanding of the pharmaceutical industry and drug development project management and regulatory affairs (e.g., Excellent communicator, able to persuasively convey both ideas and data, verbally and in writingEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Invests time in helping others to enhance their skills and perform at a higher level
Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
Ability to take risks implementing innovative solutions, accelerating time to marketIdentifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Role models respect and inclusion, creating a culture that fosters innovation12+ years pharma experience with 10+ years regulatory or 10+ years related field preferred
Regulatory (e.g. RAC or equivalent), Change Management
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.Proven ability to provide regulatory operational support and guidance.
Able to deal with issues of critical importance, provides regulatory operational advice and making reasoned decisions on regulatory operational issues.
Exercises good judgement in elevating and communicating actual or potential issues to line management.Recognized as an expert in the field.
capable of managing multiple projects within assigned timelines
Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.LOCATION & TRAVEL
Remote within the US
Travel:
The Director is expected to come to Quarterly GRA meetings in Cambridge & ad hoc travel, possibly international to Columbia, Poland & India.
Massachusetts - VirtualThe actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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