Global Regulatory Strategy Lead, Oncology Biotech

SystImmune, Inc.; Princeton (NJ); On-site; USD 200,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

STD/LTD

401(k) with company match

PTO 15 days per year

11 paid holidays

Job summary

SystImmune is seeking a Regulatory Affairs leader to drive global regulatory strategies for oncology programs, integrating scientific, medical, and regulatory perspectives. You will guide submission planning, agency interactions, and cross-functional collaboration to accelerate development timelines.

The role requires a Ph.D. with at least 5 years in pharma, deep knowledge of FDA/ICH guidance, and a proven record in global regulatory strategy across multiple regions, including China where

Qualifications

• Advanced degree (Ph.D) with deep knowledge of US FDA, ICH and international guidance.
• Minimum 5 years in pharma, with global regulatory strategy exposure in oncology.
• Experience collaborating across sponsors and geographic regions.

Responsibilities

• Develop and execute global regulatory strategies to accelerate approvals.
• Lead agency meetings and prepare briefing documents with SMEs.
• Manage global regulatory submissions (BLA/IND/CTA) and information requests.
• Monitor regulatory requirements and communicate changes to teams.
• Coordinate cross-functional teams for study-level regulatory activities.
• Maintain and update regulatory documentation throughout development.

Skills

Regulatory strategy

Pharmaceutical industry experience

Global regulatory affairs

Cross-company collaboration

Attention to detail

Education

Ph.D

Job description

SystImmune is seeking a Regulatory Affairs leader to drive global regulatory strategies for oncology programs, integrating scientific, medical, and regulatory perspectives. You will guide submission planning, agency interactions, and cross-functional collaboration to accelerate development timelines.

The role requires a Ph.D. with at least 5 years in pharma, deep knowledge of FDA/ICH guidance, and a proven record in global regulatory strategy across multiple regions, including China where