Regulatory Operations Lead — Biotech (Hybrid)

n-Lorem Foundation; San Diego (CA); Hybrid; USD 85,000 - 110,000; Full time

Job summary

n-Lorem Foundation is seeking a Regulatory Operations Coordinator / Manager in a hybrid role in California. The role reports to VP, ASO Discovery and Development and handles U.S.

regulatory operations across the portfolio, supporting preclinical and clinical teams. The successful candidate will have at least a BSc/MS in science, 3+ years in pharma/biotech or clinical research, and strong FDA/regulatory knowledge.

Qualifications

• BSc or MS degree in a scientific discipline is required.
• Minimum of 3 years of experience in pharmaceutical/biotechnology or clinical research.
• Working knowledge of FDA regulations and guidance relevant to clinical-stage drug development.
• Ability to collaborate effectively across cross-functional teams.
• Demonstrated organizational and project management skills.
• Self-motivated, proactive, and hands-on with ownership and accountability.

Responsibilities

• Collaborate with cross functional teams to develop timelines for submissions to regulatory authorities.
• Support the authoring of high-quality regulatory communications, including regulatory meeting requests, briefing packages, responses to regulatory health authority requests, and IND components.
• Track upcoming regulatory milestones, including initial submissions, hold and non-hold responses and annual reports.
• Track, maintain and file all regulatory documentation.
• Coordinate site IRB review and approval with Clinical Development team.
• Prepare and revise internal regulatory procedures for continuous improvement.
• May require up to 10% travel.

Skills

Attention to detail

Cross-functional collaboration

Project management

Self-motivated

Ownership and accountability

Education

BSc or MS in a scientific discipline

Job description

n-Lorem Foundation is seeking a Regulatory Operations Coordinator / Manager in a hybrid role in California. The role reports to VP, ASO Discovery and Development and handles U.S.

regulatory operations across the portfolio, supporting preclinical and clinical teams. The successful candidate will have at least a BSc/MS in science, 3+ years in pharma/biotech or clinical research, and strong FDA/regulatory knowledge.