Senior Global Regulatory Lead – US/EU Approvals

Scorpion Therapeutics; Florham Park (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Hutchmed International seeks a Senior Regulatory Affairs leader to establish the regulatory function and lead global product registrations for US and EU approvals. You will drive filings, timelines, and interaction with health authorities.

Ideal candidates have 10+ years in regulatory affairs with strong knowledge of policy, GCP, ICH, and drug development processes, plus leadership capabilities to coordinate global teams and CRO partners.

Qualifications

• BS in a scientific or health discipline required.
• 10+ years in regulatory affairs with US/EU filings and approvals.
• Strong knowledge of regulatory policies, GCP and ICH guidelines.

Responsibilities

• Prepare and submit INDs, NDAs and sNDAs.
• Develop submission strategies and timelines.
• Serve as primary US FDA contact.
• Facilitate health authority meetings.
• Coordinate responses across global teams and CROs.

Skills

Regulatory affairs

FDA liaison

Regulatory strategy

ICH guidelines

Communication

Education

BS in science/health

PhD/PharmD preferred

Job description

Hutchmed International seeks a Senior Regulatory Affairs leader to establish the regulatory function and lead global product registrations for US and EU approvals. You will drive filings, timelines, and interaction with health authorities.

Ideal candidates have 10+ years in regulatory affairs with strong knowledge of policy, GCP, ICH, and drug development processes, plus leadership capabilities to coordinate global teams and CRO partners.