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

Company: Takeda Pharmaceuticals
Location: Concord
Posted on: June 9, 2024

Job 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.
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 four 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 Takeda as an Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans are established and maintained, and plans & directs the seamless execution of the GRT goals. You will also lead 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. You will directly support program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations. Perform regulatory operational activities and directly oversees vendors providing operational support for assigned programs. You will report to Director, GRO Regulatory Project Management and be a part of the Global Regulatory Affairs Team.
How you will contribute:



  • As Associate Director, Global Regulatory Project Management and Strategic Planning, you will partner 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. 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. Proactively lead teams to identify and recommend solutions to problems and pathways to overcome timeline concerns and barriers for strategy execution. Develop and maintain integrated regulatory project plans and integrated SWG plans.


  • 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. Liaise and proactively engage with third party stakeholders to ensure smooth, effective and timely work flows. 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, preparing, checking and tracking regulatory data and lists 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) for assigned programs. Collaborate with the GRL in presenting operational strategies and plan statuses to key stakeholders (e.g. 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 for assigned programs.


  • Elevate high-impact business critical issues and potential critical issues together with proposed plan of action, as appropriate, in a timely manner to GRL and management.


  • Drive continuous improvement by recommending, planning and implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head. Identify and propose solutions for addressing potential systemic bottlenecks and constraints. Conduct lessons learned sessions for assigned programs; track project variances and identify root causes; detect, raise awareness and develop plan to address systemic concerns/issues.


    Minimum Requirements/Qualifications:


    • Bachelors degree required. Empahsis in Science preferred.


    • Advanced degree preferred


    • 6+ years of related experience, preferably with 4+ years in regulatory.


    • Advanced education or credentialing in regulatory affairs and project management preferred.


    • Expertise with project management related software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc).


    • Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.


    • At least one major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is preferred.


    • 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, provide regulatory operational advice and making reasoned decisions on regulatory operational issues.


      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.
      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.
      Takeda Compensation and Benefits Summary
      We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
      For Location:
      Massachusetts - Virtual
      U.S. Base Salary Range:
      $149,100.00 - $234,300.00
      The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.---The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
      U.S. based employees may be eligible for short-term and/ or long-term incentives. U.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. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
      EEO Statement
      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.
      Locations
      Massachusetts - Virtual
      Worker Type
      Employee
      Worker Sub-Type
      Regular
      Time Type
      Full time
      #LI-Remote

Keywords: Takeda Pharmaceuticals, Concord , Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience, Executive , Concord, New Hampshire

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