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Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology
Location
United States
Posted
5 days ago
Salary
$154.4K - $242.6K / year
Seniority
Lead
No structured requirement data.
Job Description
Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology
Takeda
Role Description 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 an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global Regulatory Affairs organization, based remotely. - 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. - 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. - Directly support program GRL by ensuring project management and regulatory operational support for the asset is effective and seamless. - Perform regulatory operational activities and oversee vendors providing operational support for assigned programs. Qualifications - Bachelor's degree required; emphasis in Science preferred. - Advanced degree preferred. - Minimum of 8 years 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, and business systems technology. - 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. - Proven ability to provide regulatory operational support and guidance. - Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging. - Excellent interpersonal and negotiation skills. - 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 with attention to detail. - Expertise with project management related software and tools (e.g., MS Project, OnePager, Office Timeline, SharePoint, etc.). Requirements - Ability to drive teams towards solutions and options. - Ability to provide both hands-on & supervisory regulatory operational support and project management leadership. - Ability to discern between critical and non-essential tasks. - 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. - Analytical and problem-solving skills with the ability to identify issues and opportunities. Benefits - U.S. Base Salary Range: $154,400.00 - $242,550.00. - Eligible for short-term and/or long-term incentives. - Participation in medical, dental, vision insurance, a 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, and well-being benefits. - Eligible to accrue up to 120 hours of paid vacation. - Up to 80 hours of sick time per calendar year. Company Description 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. - Offers stimulating careers and encourages innovation. - Strives for excellence in everything we do. - Fosters an inclusive, collaborative workplace.
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