Regulatory Affairs Director: NDA Strategy & Submissions

Regulatory Toolkit; San Diego (CA); On-site; USD 190,000 - 210,000; Full time

Job summary

Viking Therapeutics, Inc. seeks a Director of Regulatory Affairs to lead global regulatory strategy and oversee NDA/MAA filings. You will coordinate submissions, ensure FDA readiness, and manage external vendors in a lean, virtual operating model from our San Diego headquarters.

The role demands extensive experience with eCTD, IND/NDAs, and cross‑functional collaboration to drive submissions, lifecycle management, and health authority interactions while maintaining meticulous regulatory records.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Minimum 8 years of pharmaceutical/biotech experience, including at least 6 years in Regulatory Affairs.
• Hands-on experience preparing, authoring, and reviewing regulatory submission content.
• Demonstrated NDA/MAA experience and support through approval cycles.
• Experience with FDA eCTD submissions, and secure gateway transmission.
• Willingness to work on-site at the San Diego, CA headquarters.

Responsibilities

• Coordinate and execute global regulatory submissions and lifecycle management.
• Review and QC submission documents for scientific accuracy and regulatory compliance.
• Manage publishing timelines, vendor coordination, and gateway transmission.
• Maintain regulatory records and health authority correspondence logs.
• Collaborate with cross-functional teams and support health authority meetings.

Skills

Regulatory strategy

Leadership

Regulatory submissions

FDA eCTD submissions

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Veeva Vault RIM

docuBridge

eCTD tooling

Job description

Viking Therapeutics, Inc. seeks a Director of Regulatory Affairs to lead global regulatory strategy and oversee NDA/MAA filings. You will coordinate submissions, ensure FDA readiness, and manage external vendors in a lean, virtual operating model from our San Diego headquarters.

The role demands extensive experience with eCTD, IND/NDAs, and cross‑functional collaboration to drive submissions, lifecycle management, and health authority interactions while maintaining meticulous regulatory records.