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

About the role

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformational 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 an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. You will partner 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. You will 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 the program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless, and delivering to expectations. You will perform regulatory operational activities and directly oversee vendors providing operational support for assigned programs.

Responsibilities

• Partner with the program Global Regulatory Lead (GRL) to co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings. Oversee, plan, and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for complex programs.
• 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 levels of urgency, and maintain focus on deliverables. 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 outsourced 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 workflows. Operational support may include:
  • 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
• Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks, and mitigation management (including 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) through both scheduled and ad-hoc updates.
• Drive decision-making processes and escalate issues as needed, ensuring proactive planning to enable delivery of all regulatory milestones for assigned programs.
• Elevate high-impact business-critical issues and potential critical issues, together with proposed plans of action, in a timely manner to the 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 plans to address systemic concerns/issues.
• Consult, support, advise, and contribute to Takeda’s body of Regulatory Project Management Knowledge and Project Management processes.
• Provide training and support to other RPMs as required.
• Demonstrate Takeda Leadership behaviors.

Requirements

• Bachelor’s degree required. Emphasis in Science preferred. Advanced degree preferred.
• Minimum of 8 years of 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.
• Demonstrated expert experience leading high-performance teams and mentoring colleagues.
• 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.
• Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support is needed.
• Proven ability to provide regulatory operational support and guidance.
• Able to deal with issues of critical importance, provide regulatory operational advice, and make reasoned decisions on regulatory operational issues.
• Demonstrates leadership, problem-solving ability, flexibility, and teamwork.
• Exercises good judgment in elevating and communicating actual or potential issues to line management.
• Active participation in industry groups/forums expected.
• Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.
• Excellent interpersonal and negotiation skills.
• Demonstrates strong ability to collaboratively lead without line authority, interact, and work effectively with other departments as well as external organizations.
• Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment.
• Excellent organizational skills, ability to multitask, and attention to detail; 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.
• Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.
• Expertise with project management-related software and tools (e.g., MS Project, OnePager, Office Timeline, SharePoint, etc.).

About Takeda

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.

Pay

For Location: Massachusetts - Virtual U.S. Base Salary Range: $154,400.00 - $242,550.00. 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.

Benefits

• Eligibility to participate in medical, dental, and vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires are eligible to accrue up to 120 hours of paid vacation per calendar year.
• Eligibility for short-term and/or long-term incentives.