Global Regulatory Strategy Director — Biotech (Hybrid SF)

Proclinical Staffing; San Francisco (CA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

A growing biotechnology company in San Francisco is seeking a Senior Director, Regulatory Affairs to lead their global regulatory strategy and oversee submission activities. The position requires over 10 years of regulatory affairs experience, including 5 years at the director level. The ideal candidate will have deep knowledge of FDA regulations and experience with INDs, CTAs, and NDAs. The role is hybrid and involves collaboration with cross-functional teams to support drug development.

Qualifications

• 10+ years of regulatory affairs experience in biotechnology or pharmaceuticals.
• 5+ years in a Director level role or above.
• Experience with INDs, CTAs, NDAs, BLA, MAA.

Responsibilities

• Lead global regulatory strategy and operations.
• Oversee submission activities for clinical development.
• Manage interactions with regulatory authorities.

Skills

Regulatory strategy development

Submission activities management

Knowledge of FDA regulations

Collaboration with stakeholders

Adaptability in fast-paced environments

Education

Advanced degree (PhD, PharmD, MD, MS) or BS

Tools

eCTD submissions

RIMS tools

Job description

A growing biotechnology company in San Francisco is seeking a Senior Director, Regulatory Affairs to lead their global regulatory strategy and oversee submission activities. The position requires over 10 years of regulatory affairs experience, including 5 years at the director level. The ideal candidate will have deep knowledge of FDA regulations and experience with INDs, CTAs, and NDAs. The role is hybrid and involves collaboration with cross-functional teams to support drug development.