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

Jobleads-US

Role: Associate Director, Global Regulatory Project Management and Strategic Planning in Oncology at Takeda, remotely based.

Responsibilities

partner with the Global Regulatory Lead to develop and execute global regulatory project plans
lead cross-functional submission teams to ensure successful regulatory filings
oversee operational support activities
drive continuous process improvements
Manage relationships with vendors and internal stakeholders
prepare reports on regulatory milestones
escalation critical issues

Qualifications

Bachelor's degree in Science or related field
8+ years of regulatory project management experience, including global drug development and late-stage filings
demonstrated leadership in cross-functional teams
expertise in regulatory submissions, eCTD filings, and compliance, particularly within oncology

Preferred

advanced degrees or certifications in regulatory affairs or project management
experience with global regulatory strategies and post-market activities

HighValue: oncology, late-stage development, global regulatory submissions, cross-functional leadership, vendor management, regulatory strategy planning, and operational support.

WorkSetup: remote in the USA, with hybrid options.

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Vacancy posted 1 day ago

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