Global Oncology Regulatory Director

US Diversity Job Search; Billerica (MA); On-site; USD 172,000 - 231,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

US Diversity Job Search is seeking a Director of Global Regulatory Affairs to define and execute global regulatory strategies for designated oncology programs, ensuring timely, compliant approvals across geographies. Lead cross-functional teams and manage FDA/EMA interactions to optimize submissions and lifecycle management.

The role requires an advanced degree and at least 6 years regulatory experience, including 3+ years in Oncology, with strong leadership and communication skills.

Qualifications

• Advanced degree required (PhD/PharmD/MD) with regulatory expertise.
• Proven track record in regulatory strategy development for oncology.
• Strong written and spoken English; multilingual skills a plus.

Responsibilities

• Develop and execute global regulatory strategy for oncology programs.
• Lead regulatory submissions and lifecycle management across regions.
• Manage interactions with health authorities (FDA/EMA) for approvals and labeling.
• Provide regulatory input to portfolio teams and drive data-driven decisions.
• Lead a cross-functional team to align regulatory timelines and deliverables.
• Ensure compliance with global/regional regulations and internal governance.
• Mentor junior regulatory staff and promote regulatory excellence.
• Monitor regulatory landscape to adapt strategies to changes.
• Collaborate with patient- and science-focused teams to support milestones.

Skills

Strategic regulatory leadership

Cross-functional leadership

HA/FDA/EMA interactions

English communication

Education

Advanced degree (PhD/PharmD/MD)

Job description

US Diversity Job Search is seeking a Director of Global Regulatory Affairs to define and execute global regulatory strategies for designated oncology programs, ensuring timely, compliant approvals across geographies. Lead cross-functional teams and manage FDA/EMA interactions to optimize submissions and lifecycle management.

The role requires an advanced degree and at least 6 years regulatory experience, including 3+ years in Oncology, with strong leadership and communication skills.