Regulatory Affairs Executive Director — Biologics & RTOR

Dren Bio, Inc.; San Carlos (CA); On-site; USD 230,000 - 280,000; Full time

Benefits offered by this job

Equity incentive awards

Employer sponsored benefits

Job summary

Dren Bio, Inc. is seeking a Senior Director/Executive Director of Regulatory Affairs to lead global regulatory strategy from clinical development through marketing approval.

You will partner with cross-functional teams and manage interactions with the FDA and other health authorities to drive expedited pathways and successful BLA submissions. Ideal candidates bring 12+ years in regulatory affairs for biologics, with strong leadership, strategic thinking, and hands-on regulatory execution.

Qualifications

• Bachelor's degree in a scientific, life sciences, pharmacy, or related discipline.
• Minimum of 12+ years of progressive regulatory affairs experience in biotechnology or pharmaceutical industry.
• Experience leading regulatory strategy for biologics with direct FDA interaction.
• Experience leading or playing a major regulatory leadership role in BLA planning and submissions; PRIME/RTOR experience is a plus.

Responsibilities

• Lead global regulatory strategy for designated development programs, integrating clinical/nonclinical/CMC/safety into dated regulatory plans.
• Provide proactive regulatory guidance to optimize drug development and marketing authorization strategies across regions.
• Lead FDA interactions, including meeting strategy, briefing materials, and follow-up commitments.
• Lead regulatory strategy and execution for BLA submissions end to end, including content strategy and cross-functional coordination.
• Develop and execute expedited-pathway strategies (Fast Track/Breakthrough/Orphan/PRIME) and manage EMA interactions.
• Coordinate regulatory planning for rolling submissions and Real-Time Oncology Review (RTOR) where applicable.

Skills

Regulatory strategy

FDA interactions

BLA submissions

Lead cross-functional teams

Regulatory writing

Education

Bachelor's degree in a scientific field

MS/PharmD/PhD preferred

Job description

Dren Bio, Inc. is seeking a Senior Director/Executive Director of Regulatory Affairs to lead global regulatory strategy from clinical development through marketing approval.

You will partner with cross-functional teams and manage interactions with the FDA and other health authorities to drive expedited pathways and successful BLA submissions. Ideal candidates bring 12+ years in regulatory affairs for biologics, with strong leadership, strategic thinking, and hands-on regulatory execution.