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

Scorpion Therapeutics; Cambridge (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Takeda is seeking an Associate Director of Global Regulatory Project Management and Strategic Planning in Oncology. The role is remotely based in the USA, with potential hybrid options, partnering with the Global Regulatory Lead to shape and execute comprehensive regulatory strategies.

You will lead diverse, cross-functional teams through global submissions, drive process improvements, and manage vendor relationships while delivering milestones in an oncology-focused program portfolio.

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 oncology regulatory compliance.

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.
• Escalate critical issues.

Skills

Regulatory project management

Cross-functional leadership

Regulatory submissions

eCTD filings

Oncology regulatory expertise

Vendor management

Education

Bachelor's degree in Science

Job description

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.