Global Regulatory Strategy Leader for Oncology & Medical Writing

SystImmune, Inc.; Princeton (NJ); On-site; USD 340,000 - 420,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

STD/LTD

401(k) with company match

15 days PTO

11 paid holidays

Job summary

SystImmune, Inc. is a pioneering biopharmaceutical company focused on cancer therapies with a strong presence in New Jersey and Washington state.

The VP/SVP, Head of Regulatory Affairs will shape global regulatory strategy across the oncology portfolio and guide cross‑functional teams through development, registration, and lifecycle management. The role leads interactions with FDA/EMA and builds a high‑performing Regulatory Affairs and Medical Writing function, ensuring rigorous, timely

Qualifications

• 15+ years of progressive Regulatory Affairs experience, including senior leadership roles.
• Extensive experience in oncology drug development and global regulatory strategy.
• Track record of leading major regulatory submissions (INDs; BLA/MAA preferred).
• Experience leading interactions with FDA and other health authorities.

Responsibilities

• Develop and execute global regulatory strategies across the oncology portfolio from early development to lifecycle management.
• Provide regulatory guidance to executive leadership and cross‑functional teams on clinical development plans and pivotal trials.
• Lead preparation, submission, and management of major regulatory applications (INDs, BLAs, MAAs).
• Build and lead a high‑performing Regulatory Affairs and Medical Writing organization.

Skills

Regulatory strategy

Leadership

Biopharma

Oncology

Regulatory submissions

FDA interactions

Education

Advanced degree in life sciences/related field

Job description

SystImmune, Inc. is a pioneering biopharmaceutical company focused on cancer therapies with a strong presence in New Jersey and Washington state.

The VP/SVP, Head of Regulatory Affairs will shape global regulatory strategy across the oncology portfolio and guide cross‑functional teams through development, registration, and lifecycle management. The role leads interactions with FDA/EMA and builds a high‑performing Regulatory Affairs and Medical Writing function, ensuring rigorous, timely