Director, Regulatory Affairs — Oncology Global Submissions

BLOSSOMHILL THERAPEUTICS INC; San Diego (CA); Vor Ort; USD 209.000 - 249.000; Vollzeit

Zusammenfassung

BlossomHill Therapeutics seeks a Director, Regulatory Affairs to lead global regulatory strategies and submission execution for its clinical programs. The role reports to the Executive Director, Regulatory Affairs and involves coordinating cross‑functional teams to ensure timely, compliant filings.

The successful candidate will manage regulatory strategy, document preparation, and interactions with Health Authorities across INDs/CTAs, with onsite work in San Diego.

Qualifikationen

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• Advanced degree (Master’s or PhD) preferred.
• Approximately 8–10 years of regulatory experience in pharmaceutical/biotech.
• Excellent understanding of global regulations (FDA, EMA, PMDA).
• Experience with regulatory filings, electronic submissions (INDs/CTAs).
• Experience in oncology programs; lung cancer experience is a plus.

Aufgaben

• Develop US/global regulatory strategies for assigned programs and plan/regulatory submissions.
• Lead responses to Health Authority questions for assigned programs.
• Create Regulatory Strategy Documents and Project Plans; document targeting and messaging.
• Provide regulatory guidance to drive compliant clinical development.
• Maintain regulatory files per internal standards.
• Collaborate with cross-functional teams to prepare and align regulatory documents.

Kenntnisse

Regulatory strategy

Global submissions

Regulatory guidance

Project management

Communication skills

Oncology regulatory

Ausbildung

Bachelor’s degree in science/healthcare

Master’s or PhD preferred

Tools

eCTD submissions

Document management systems

Jobbeschreibung

BlossomHill Therapeutics seeks a Director, Regulatory Affairs to lead global regulatory strategies and submission execution for its clinical programs. The role reports to the Executive Director, Regulatory Affairs and involves coordinating cross‑functional teams to ensure timely, compliant filings.

The successful candidate will manage regulatory strategy, document preparation, and interactions with Health Authorities across INDs/CTAs, with onsite work in San Diego.