Senior Director Regulatory Strategy

EPM Scientific; Hayward (CA); On-site; USD 240,000 - 320,000; Full time

Job summary

EPM Scientific is supporting a clinical-stage oncology biotech seeking a Senior Director of Regulatory Affairs. This leader will build regulatory strategy from development to commercialization and manage major filings with FDA, EMA, and global health authorities.

The role requires senior leadership, cross-functional collaboration, and a proactive regulatory posture to advance a robust oncology pipeline. The position offers ownership, visibility to senior leadership, and a chance to shape

Qualifications

• Advanced degree with 12+ years in regulatory affairs, or a Bachelor's degree with 15+ years; PhD or PharmD preferred.
• Proven record leading submissions and direct FDA interactions.
• Oncology regulatory experience strongly preferred.

Responsibilities

• Develop and carry out regulatory strategy from development through approval and commercialization
• Lead preparation and submission of major filings (IND, NDA, MAA)
• Serve as a primary contact with FDA and global health authorities, and prepare teams for and lead agency meetings
• Act as the strategic regulatory partner to R&D, Clinical Development and Quality
• Spot regulatory risks early and put proactive mitigation plans in place
• Keep up to date on changing FDA and international requirements and keep the company compliant (GCP/GLP)
• Build, mentor and scale the regulatory team as the pipeline advances

Skills

Regulatory strategy

FDA interactions

Oncology regulatory

ICH guidelines

Leadership

Communication

Project management

Cross-functional leadership

Education

Advanced degree (PhD/PharmD/MD)

Bachelor's degree + 15+ years regulatory experience

Job description

Senior Director, Regulatory Affairs - Clinical-Stage Oncology Biotech

ABOUT THE COMPANY

Our client is a clinical-stage oncology company co-founded by a Nobel Prize laureate. Its drug discovery platform builds on Nobel Prize-winning microscopy that lets scientists watch individual proteins move inside living cells. The company is led by the former R&D head behind one of the most successful cancer immunotherapies in the industry. It has raised more than $1B and is advancing a lead program in a mid-to-late stage trial, with a deep pipeline behind it.

ABOUT THE ROLE

The Senior Director, Regulatory Affairs, will set and lead regulatory strategy at a defining point in the company's growth. This is a rare chance to build a regulatory function from the ground up, with real ownership and visibility to senior leadership.

DESCRIPTION OF THE ROLE

• Develop and carry out regulatory strategy from development through approval and commercialization
• Lead preparation and submission of major filings (IND, NDA, MAA)
• Serve as a primary contact with FDA and global health authorities, and prepare teams for and lead agency meetings
• Act as the strategic regulatory partner to R&D, Clinical Development and Quality
• Spot regulatory risks early and put proactive mitigation plans in place
• Keep up to date on changing FDA and international requirements and keep the company compliant (GCP/GLP)
• Build, mentor and scale the regulatory team as the pipeline advances

ESSENTIAL REQUIREMENTS FOR ROLE

• Advanced degree with 12+ years in regulatory affairs, or a Bachelor's degree with 15+ years; PhD or PharmD preferred
• Proven record leading submissions and direct FDA interactions
• Oncology regulatory experience strongly preferred
• Strong working knowledge of FDA, EMA and ICH guidelines
• Experience managing direct reports and leading cross-functional teams
• Strategic mindset paired with willingness to roll up your sleeves
• Excellent communication, negotiation and project management skills