Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology
Takeda
August 07, 2026
Remote
United States
$154,400 - $242,550 USD yearly
Operations
Responsibilities:
- Partner with the Global Regulatory Lead (GRL) to establish/maintain global regulatory project plans and direct seamless execution of Global Regulatory Team (GRT) goals.
- Lead cross-functional submission working groups (SWGs) to deliver successful regulatory submissions/filings and Health Authority (HA) outcomes across early-to-late phases.
- Provide regulatory operational support for assigned programs/assets; oversee vendor operational support.
- Co-lead/facilitate GRT and product-specific SWG meetings; oversee planning and delivery of regulatory submissions per regulatory strategy.
- Ensure Global Product Team (GPT) regulatory goals are cascaded and the Global Regulatory Strategy Plan is operationalized; align operational plans with Global Project Management (GPM) and TAU/BU strategies.
- Drive deliverables, create integrated regulatory project and SWG plans, identify solutions to issues/timeline barriers.
- Provide/oversee regulatory operational support (e.g., drafting forms/cover letters, logistics for HA meetings, notifications, document workflows, regulatory data/lists in systems).
- Report metrics on milestone status, risks/constraints, and mitigation; escalate high-impact issues with proposed action plans.
- Lead continuous improvement via process changes and lessons-learned; consult/train/support others in Regulatory Project Management knowledge/processes; demonstrate leadership behaviors.
Minimum requirements/qualifications & skills:
- Bachelor’s required (Science preferred); advanced degree preferred.
- 8+ years related experience (preferably 4+ in Global Regulatory Affairs) with late-stage filing experience highly preferred.
- Significant global drug development regulations/submissions/lifecycle management/compliance/business systems process experience.
- At least two major eCTD (original/supplement) registrations and experience with minor (amendment) filings in the USA or more jurisdictions.
- Strong leadership, communication, negotiation, organizational, analytical/problem-solving, and matrix/team leadership skills.
- Ability to provide regulatory operational guidance and make reasoned decisions; excellent verbal/written communication and presentation skills.
- Expertise with PM tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).
Benefits (if eligible, as stated): medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 sick hours/year, and up to 120 hours paid vacation for new hires.
- Partner with the Global Regulatory Lead (GRL) to establish/maintain global regulatory project plans and direct seamless execution of Global Regulatory Team (GRT) goals.
- Lead cross-functional submission working groups (SWGs) to deliver successful regulatory submissions/filings and Health Authority (HA) outcomes across early-to-late phases.
- Provide regulatory operational support for assigned programs/assets; oversee vendor operational support.
- Co-lead/facilitate GRT and product-specific SWG meetings; oversee planning and delivery of regulatory submissions per regulatory strategy.
- Ensure Global Product Team (GPT) regulatory goals are cascaded and the Global Regulatory Strategy Plan is operationalized; align operational plans with Global Project Management (GPM) and TAU/BU strategies.
- Drive deliverables, create integrated regulatory project and SWG plans, identify solutions to issues/timeline barriers.
- Provide/oversee regulatory operational support (e.g., drafting forms/cover letters, logistics for HA meetings, notifications, document workflows, regulatory data/lists in systems).
- Report metrics on milestone status, risks/constraints, and mitigation; escalate high-impact issues with proposed action plans.
- Lead continuous improvement via process changes and lessons-learned; consult/train/support others in Regulatory Project Management knowledge/processes; demonstrate leadership behaviors.
Minimum requirements/qualifications & skills:
- Bachelor’s required (Science preferred); advanced degree preferred.
- 8+ years related experience (preferably 4+ in Global Regulatory Affairs) with late-stage filing experience highly preferred.
- Significant global drug development regulations/submissions/lifecycle management/compliance/business systems process experience.
- At least two major eCTD (original/supplement) registrations and experience with minor (amendment) filings in the USA or more jurisdictions.
- Strong leadership, communication, negotiation, organizational, analytical/problem-solving, and matrix/team leadership skills.
- Ability to provide regulatory operational guidance and make reasoned decisions; excellent verbal/written communication and presentation skills.
- Expertise with PM tools (e.g., MS Project, OnePager, Office Timeline, SharePoint).
Benefits (if eligible, as stated): medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 sick hours/year, and up to 120 hours paid vacation for new hires.