Regulatory Strategy Director - Oncology Biotech

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

Benefits offered by this job

Premium health coverage for employees

401(k) plan with company match

15 PTO days per year

11 paid holidays

SystImmune career growth opportunities

Job summary

SystImmune, a Redmond, WA and Princeton, NJ based biopharmaceutical company, seeks a Regulatory Affairs leader to drive global regulatory strategy for preclinical and clinical oncology programs, interfacing with FDA, EMA, PMDA, and other agencies. The role requires 5+ years in pharma, a Ph.D.

or equivalent, and strong experience in global regulatory strategy, with collaboration across sponsors and regions including China.

Qualifications

• Advanced degree such as Ph.D.
• Minimum 5 years of pharma industry experience with global regulatory strategy
• Experience in oncology product development and biologics is preferred

Responsibilities

• Drive global regulatory strategy for preclinical/clinical oncology programs.
• Lead agency meetings and briefing documents.
• Manage global submissions including BLA/IND/CTAs.
• Maintain knowledge of FDA/ICH guidance and changes.
• Collaborate with cross-functional teams across regions.
• Ensure regulatory compliance and manage agency inquiries.
• Provide updates on conditions/commitments and timelines.

Skills

Regulatory strategy

Global regulatory experience

Cross-functional collaboration

Oncology

Education

Ph.D

Job description

SystImmune, a Redmond, WA and Princeton, NJ based biopharmaceutical company, seeks a Regulatory Affairs leader to drive global regulatory strategy for preclinical and clinical oncology programs, interfacing with FDA, EMA, PMDA, and other agencies. The role requires 5+ years in pharma, a Ph.D.

or equivalent, and strong experience in global regulatory strategy, with collaboration across sponsors and regions including China.